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Publication numberUS7416554 B2
Publication typeGrant
Application numberUS 10/672,375
Publication dateAug 26, 2008
Filing dateSep 25, 2003
Priority dateDec 11, 2002
Fee statusPaid
Also published asUS8216260, US8540740, US20040147958, US20090018552, US20120277775
Publication number10672375, 672375, US 7416554 B2, US 7416554B2, US-B2-7416554, US7416554 B2, US7416554B2
InventorsCang Lam, Rich Ewers, Alexander Khairkhahan, Vahid C. Saadat
Original AssigneeUsgi Medical Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Apparatus and methods for forming and securing gastrointestinal tissue folds
US 7416554 B2
Abstract
Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point, moving the first tissue contact point from a position initially distal to a second tissue contact point to a position proximal of the second contact point to form a tissue fold, and extending an anchor assembly through the tissue fold near the second tissue contact point. Adjustable anchor assemblies, as well as anchor delivery systems, are also provided.
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Claims(3)
1. Apparatus for securing a tissue fold within a patient, the apparatus comprising:
an elongate member having a proximal end and a distal end;
application apparatus extending from the distal end of said elongate member and having a distal portion adapted to engage a tissue fold within a patient; and
an anchor assembly having proximal and distal anchors connected by a suture, said suture having a proximal end and a distal end,
wherein the anchor assembly is adapted for adjustment of the length of suture disposed between the proximal and distal anchors while the anchor assembly is disposed across the tissue fold;
further comprising an anchor delivery system adapted to deploy and secure the anchor assembly across the tissue fold;
wherein the anchor delivery system comprises a flexible delivery tube having a lumen, and a hollow needle disposed within the lumen, said anchor delivery system having a distal region extending from the distal end of said elongate member;
wherein the distal anchor passes through the hollow needle during delivery;
wherein the anchor delivery system further comprises an anchor tube coupled to a distal region of the flexible delivery tube, and wherein the proximal anchor is disposed within the anchor tube during delivery;
wherein the anchor delivery system further comprises a trap mechanism located substantially within the distal region of said anchor delivery system, said trap mechanism being adapted to reversibly trap the suture at or near its proximal end to facilitate adjustment of the length of suture disposed between the proximal and distal anchors, and wherein the trap mechanism is adapted to release the suture after the length of suture has been adjusted.
2. Apparatus for securing a tissue fold within a patient, the apparatus comprising:
an elongate member having a proximal end and a distal end;
application apparatus extending from the distal end of said elongate member and having a distal region adapted to engage a tissue fold within a patient; and
an anchor assembly having proximal and distal anchors connected by a suture, said suture having a proximal end and a distal end,
wherein the anchor assembly is adapted for adjustment of the length of suture disposed between the proximal and distal anchors while the anchor assembly is disposed across the tissue fold;
further comprising an anchor delivery system adapted to deploy and secure the anchor assembly across the tissue fold;
wherein the anchor delivery system comprises a flexible delivery tube having a lumen, and a hollow needle disposed within the lumen, said anchor delivery system having a distal region extending from the distal end of said elongate member;
wherein the anchor assembly passes through the hollow needle during delivery;
wherein the anchor delivery system further comprises a trap mechanism located substantially within the distal region of said anchor delivery system, said trap mechanism being adapted to reversibly trap the suture at or near its proximal end to facilitate adjustment of the length of suture disposed between the proximal and distal anchors, and wherein the trap mechanism is adapted to release the suture after the length of suture has been adjusted.
3. The apparatus of claim 2, further comprising an anchor pushrod in communication with an interior of the needle, the anchor pushrod adapted to eject the anchor assembly from the needle.
Description
REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. provisional patent application Ser. No. 60/500,627, filed Sep. 5, 2003, and is a Continuation-In-Part of U.S. patent application Ser. No. 10/612,170, filed Jul. 1, 2003, as well as U.S. patent application Ser. No. 10/639,162, filed Aug. 11, 2003, both of which claim priority from U.S. provisional patent application Ser. No. 60/433,065, filed Dec. 11, 2002, all of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for intraluminally forming and securing gastrointestinal (“GI”) tissue folds. More particularly, the present invention relates to methods and apparatus for reducing the effective cross-sectional area of a gastrointestinal lumen.

BACKGROUND OF THE INVENTION

Morbid obesity is a serious medical condition pervasive in the United States and other countries. Its complications include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy.

Several surgical techniques have been developed to treat morbid obesity, e.g., bypassing an absorptive surface of the small intestine, or reducing the stomach size. These procedures are difficult to perform in morbidly obese patients because it is often difficult to gain access to the digestive organs. In particular, the layers of fat encountered in morbidly obese patients make difficult direct exposure of the digestive organs with a wound retractor, and standard laparoscopic trocars may be of inadequate length.

In addition, previously known open surgical procedures may present numerous life-threatening postoperative complications, and may cause a typical diarrhea, electrolytic imbalance, unpredictable weight loss and reflux of nutritious chyme proximal to the site of the anastamosis. Further, the sutures or staples that are often used in these surgical procedures may require extensive training by the clinician to achieve competent use, and may concentrate significant force over a small surface area of the tissue, thereby potentially causing the suture or staple to tear through the tissue.

The gastrointestinal lumen includes four tissue layers, wherein the mucosa layer is the top tissue layer followed by connective tissue, the muscularis layer and the serosa layer. One problem with conventional gastrointestinal reduction systems is that the anchors (or staples) must engage at least the muscularis tissue layer in order to provide a proper foundation. In other words, the mucosa and connective tissue layers typically are not strong enough to sustain the tensile loads imposed by normal movement of the stomach wall during ingestion and processing of food. In particular, these layers tend to stretch elastically rather than firmly hold the anchors (or staples) in position, and accordingly, the more rigid muscularis and/or serosa layer must be engaged. This problem of capturing the muscularis or serosa layers becomes particularly acute where it is desired to place an anchor or other apparatus transesophageally rather than intraoperatively, since care must be taken in piercing the tough stomach wall not to inadvertently puncture adjacent tissue or organs.

In view of the aforementioned limitations, it would be desirable to provide methods and apparatus for forming gastrointestinal tissue folds that achieve gastric reduction by reconfiguring the GI lumen of a patient.

It would be desirable to provide methods and apparatus for forming gastrointestinal tissue folds using anchors that can be reconfigured from a reduced delivery profile to an expanded deployed profile.

It also would be desirable to provide methods and apparatus for forming gastrointestinal tissue folds, wherein an anchor assembly is extended across stomach folds that include the muscularis and serosa tissue layers.

It further would be desirable to provide methods and apparatus for forming gastrointestinal tissue folds, wherein the anchor assembly is deployed in a manner that reduces a possibility of injuring neighboring organs.

It still further would be desirable to provide methods and apparatus for forming gastrointestinal tissue folds, wherein reduced training of a clinician is required to achieve competent use of the anchor assembly.

SUMMARY OF THE INVENTION

In view of the foregoing, it is an object of the present invention to provide methods and apparatus for forming gastrointestinal tissue folds that achieve gastric reduction by reconfiguring the GI lumen of a patient.

It is another object of the present invention to provide methods and apparatus for forming gastrointestinal tissue folds using anchors that can be reconfigured from a reduced delivery profile to an expanded deployed profile.

It is an additional object of this invention to provide methods and apparatus for forming gastrointestinal tissue folds in which an anchor assembly is extended across stomach folds that include the muscularis and serosa tissue layers.

It is a further object of the present invention to provide methods and apparatus for forming gastrointestinal tissue folds, wherein the anchor assembly is deployed in a manner that reduces a possibility of injuring neighboring organs.

It is yet another object to provide methods and apparatus for forming gastrointestinal tissue folds, wherein reduced training of a clinician is required to achieve competent use of the anchor assembly.

These and other objects of the present invention are accomplished by providing a catheter configured for advancement into a patient's gastrointestinal lumen to form a gastrointestinal tissue fold. In one preferred embodiment, the catheter has a distal region including a tissue grabbing assembly adapted to engage and stretch a portion of the tissue wall of the GI lumen at a first tissue contact point. A second tissue contact point is then established with the tissue wall at a location initially proximal of, or in line with, the first tissue contact point. The tissue engaged by the tissue grabbing assembly then is moved to a position proximal of the second tissue contact point to form a tissue fold, and an anchor assembly may be delivered across the tissue fold. Preferably, delivery of the anchor assembly across the tissue fold includes delivering the anchor assembly across the muscularis and serosa layers of the tissue wall.

In a preferred embodiment, the tissue grabbing assembly is carried on a first flexible tube associated with the distal region of the catheter, and the anchor assembly is delivered by an anchor delivery system disposed within a second flexible tube associated with the distal region of the catheter. The tissue grabbing assembly may comprise any of a number of mechanisms configured to engage the tissue wall, including a pair of jaws configured to move between open and closed positions, a plurality of linearly translating barbs, or one or more needles or hooks. The first tissue contact point may be moved from a tissue engagement position distal to, or in line with, the second tissue contact point, to the tissue folding position by any of a number of mechanisms, including a hinge assembly or a treadmill assembly.

More preferably, the distal region of the catheter includes a bendable section that permits the first tissue contact point to be positioned relative to the second tissue contact point so that the tissue fold is oriented substantially perpendicular to the anchor delivery system. In this manner, the anchor delivery system, when deployed, pierces the tissue fold and exits into the interior of the GI lumen, rather than the exterior of the tissue wall, thereby reducing a risk of injury to adjacent organs.

The anchor assembly delivery system of the present invention preferably comprises a needle or obturator adapted to pierce the tissue fold and deliver an anchor assembly. In one preferred embodiment, the anchor assembly comprises a pair of rod-like anchors that are delivered through a needle in a reduced delivery profile, wherein the longitudinal axis of the rods is substantially parallel to the longitudinal axis of the needle. Once ejected from the needle, the rods rotate about 90 degrees to engage the tissue. In other embodiments, the anchor assembly may comprise anchors of various shaped delivered, for example, over the exterior of an obturator.

Methods of using the apparatus of the present invention also are provided.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and advantages of the present invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:

FIGS. 1A and 1B are, respectively, a side view and detail view of apparatus of the present invention for forming a gastrointestinal fold in accordance with the principles of the present invention;

FIGS. 2A and 2B are side-sectional views of a tissue grabbing assembly suitable for use with the apparatus of FIG. 1;

FIGS. 3A-3E are side views illustrating a method of using the apparatus of FIG. 1 to form a gastrointestinal fold;

FIGS. 4A-4C are side-sectional views of an anchor assembly and delivery system suitable for use with apparatus of the present invention;

FIGS. 5A and 5B are side-sectional views of another anchor assembly suitable for use with apparatus of the present invention;

FIGS. 6A and 6B are side-sectional views of another alternative anchor assembly suitable for use with apparatus of the present invention;

FIGS. 7A-7C are, respectively, a schematic side-sectional view of a unidirectionally adjustable anchor assembly suitable for use with apparatus of the present invention, schematic side-sectional views of alternative techniques for fixing the distal anchor of the assembly, and a cross-sectional view of the proximal anchor taken along section line A-A of FIG. 7A;

FIGS. 8A and 8B are schematic cross-sectional views illustrating the unidirectional adjustment capability of the anchor assembly of FIG. 7;

FIGS. 9A-9C are schematic cross-sectional views of alternative embodiments of the proximal anchor of the anchor assembly of FIG. 7;

FIGS. 10A and 10B are schematic cross-sectional views of an alternative unidirectionally adjustable anchor assembly suitable for use with apparatus of the present invention;

FIGS. 11A-11C are, respectively, a schematic side-view of another alternative unidirectionally adjustable anchor assembly suitable for use with the present invention, and cross-sectional views of the same taken along section line B-B of FIG. 11A;

FIG. 12 is a schematic cross-sectional view of an alternative unidirectionally adjustable anchor assembly comprising pivoting paddles;

FIG. 13 is a schematic cross-sectional view of an alternative unidirectionally adjustable anchor assembly comprising spring material;

FIGS. 14A-14B are schematic side-sectional views of alternative unidirectionally adjustable anchor assemblies comprising one-way valves;

FIGS. 15A-15C are side-sectional and detail views of alternative unidirectionally adjustable anchor assemblies comprising slipknots;

FIGS. 16A-16C are, respectively, a schematic side-sectional view of a bi-directionally adjustable anchor assembly comprising a locking mechanism, and cross-sectional views of the same taken along section line C-C of FIG. 16A;

FIGS. 17A-17D are perspective views of alternative anchors suitable for use with the anchor assemblies of the present invention;

FIGS. 18A-18D are side views of alternative apparatus for forming a gastrointestinal fold;

FIG. 19 is a cross-sectional view of the apparatus of FIGS. 18A-18D;

FIGS. 20A-20D are side views of further alternative apparatus for forming a gastrointestinal tissue fold in accordance with the principles of the present invention;

FIGS. 21A-21G are schematic side-sectional views of an anchor delivery system adapted for use with the adjustable anchor assemblies of FIGS. 7-17, illustrating a method of delivering the unidirectionally adjustable anchor assembly of FIG. 7 across a tissue fold;

FIGS. 22A and 22B are, respectively, a schematic side-view, partially in section, and an end-view of an alternative anchor delivery system adapted for use with the adjustable anchor assemblies of FIGS. 7-17, wherein the proximal anchor is disposed within a separate delivery tube;

FIG. 23 is a schematic side-sectional view of an alternative anchor delivery system adapted for use with the adjustable anchor assemblies of FIGS. 7-17, wherein both the proximal and distal anchors are loaded within the needle; and

FIG. 24 is a schematic side-sectional view of an alternative embodiment of the anchor delivery system of FIG. 23 comprising motion limitation apparatus.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the principles of the present invention, methods and apparatus are provided for intraluminally forming and securing gastrointestinal (“GI”) tissue folds, for example, to reduce the effective cross-sectional area of a GI lumen. These methods and apparatus may be used to treat obesity by approximating the walls of a gastrointestinal lumen to narrow the lumen, thus reducing the area for absorption in the stomach or intestines. More particularly, the present invention involves endoscopic apparatus that engages a tissue wall of the gastrointestinal lumen, creates a tissue fold and disposes an anchor assembly through the tissue fold. Preferably, the anchor assembly is disposed through the muscularis and/or serosa layers of the gastrointestinal lumen. In operation, a distal tip of the probe engages the tissue and then moves the engaged tissue to a proximal position relative to the catheter tip, thereby providing a substantially uniform plication of predetermined size.

Formation of a tissue fold preferably is accomplished using two tissue contact points that are separated by a linear or curvilinear distance, wherein the separation distance between the tissue contact points affects the length and/or depth of the fold. In operation, a tissue grabbing assembly engages the tissue wall in its normal state (i.e., non-folded and substantially flat), thus providing a first tissue contact point. The first tissue contact point then is moved to a position proximal of a second tissue contact point to form the tissue fold. An anchor assembly then may be extended across the tissue fold at the second tissue contact point.

More preferably, the first tissue contact point is used to engage and then stretch or rotate the tissue wall over the second tissue contact point to form the tissue fold. The tissue fold is then articulated to a position so that a portion of the tissue fold overlies the second tissue contact point at an orientation that is substantially normal to the tissue fold. An anchor then is delivered across the tissue fold at or near the second tissue contact point.

Referring to FIG. 1, apparatus 10 of the present invention comprises torqueable catheter 11 having distal region 12 from which first and second interconnected flexible tubes 13 and 14 extend, and proximal region 15 having handle 16 and actuator 17. Catheter 11 is configured for insertion through a patient's mouth and esophagus into the gastrointestinal lumen. Tissue grabbing assembly 18 is disposed on the distal end of flexible tube 13, and is coupled to actuator 17 via control wire 19 that extends through flexible tube 13.

As better illustrated in FIG. 1B, flexible tubes 13 and 14 are connected via hinge assembly 20 that comprises link 21 attached to flexible tube 13 at pivot point 22 and attached to flexible tube 14 at pivot point 23. Hinge assembly 20 prevents tissue grabbing assembly 18 from moving more than a predetermined distance relative to distal end 24 of flexible tube 14.

Still referring to FIG. 1B, flexible tubes 13 and 14 preferably include bendable sections 25 and 26, respectively, that comprise a plurality of through-wall slots 27 to enhance flexibility of the tube. Preferably, flexible tubes 13 and 14 are made from stainless steel with an etched or laser-cut slot pattern. More preferably, the slot pattern is a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of tubes 13 and 14.

Referring to FIGS. 2A and 2B, tissue grabbing assembly 18 comprises pair of jaws 28 a, 28 b arranged to rotate about pivot point 29 between an open configuration (FIG. 2A) and a closed configuration (FIG. 2B). Control wire 19 is coupled via pivot point 30 to arms 31 a and 31 b. Arms 31 a and 31 b are in turn pivotally coupled to jaws 28 a and 28 b, respectively, at pivot points 32 a and 32 b. Each of jaws 28 a and 28 b preferably includes sharpened teeth 33 disposed near its distal ends to facilitate grasping of the tissue wall of the GI lumen.

Control wire 19 is coupled to actuator 17 of handle 16 so that translation of the wire within flexible tube 13 causes the jaws to open or close. In particular, urging control wire distally (as indicated by arrow A in FIG. 2A) moves pivot point 30 distally, thereby forcing the jaws to open. Urging control wire 19 proximally (as indicated by arrow B in FIG. 2B) moves pivot point 30 proximally, thereby forcing the jaws to close together. In alternative embodiments, tissue grabbing assembly 18 may comprise a grappling hook or fork, or plurality of needles coupled to the distal end of flexible tube 13.

Flexible tube 14 is affixed to and immovable within catheter 11, while flexible tube 13 is coupled to catheter 11 only via hinge 20. Accordingly, when control wire 19 is extended in the distal direction, flexible tube 13 is carried in the distal direction. When control wire 19 is retracted in the proximal direction, flexible tube remains stationary until jaws 28 a and 28 b close together, after which further retraction of control wire 19 by moving actuator 17 causes flexible tube 13 to buckle in bendable region 25, as described hereinafter.

Referring now to FIGS. 1 and 3A-3E, operation of apparatus 10 is described to create a tissue fold in a tissue wall of a GI lumen. In FIG. 3A, distal region 12 of catheter 11 is positioned within a patient's GI lumen transesophageally, and jaws 28 a and 28 b of tissue grabbing assembly 18 are opened by moving actuator 17 to the distal-most position on handle 16. As depicted in FIG. 3B, actuator 17 may then be moved proximally until the jaws of tissue grabbing assembly 18 engage a portion of tissue wall W at contact point P1.

Referring to FIG. 3C, after the tissue wall has been engaged at contact point P1, flexible tube 13 is urged proximally within catheter 11 by further proximal retraction of control wire 19 to stretch tissue wall W and create tissue fold F. During this movement of flexible tube 13, link 21 of hinge assembly 20 causes tissue grabbing assembly 18 to move from a position distal to distal end 24 of flexible tube 14, to a position proximal of distal end 24 of flexible tube 14. Bendable sections 25 and 26 of flexible tubes 13 and 14, respectively, accommodate any lateral motion caused by operation of hinge assembly 20. Advantageously, formation of fold F facilitates the penetration of the tissue wall by a needle and subsequent delivery of an anchor assembly, as described hereinafter.

Referring to FIG. 3D, additional proximal movement of actuator 17 causes flexible tubes 13 and 14 to buckle at bendable sections 25 and 26. Hinge assembly 20 transmits force applied to flexible tube 13 via control wire 19 and actuator 17 to the distal tip 24. Preferably, flexible tube 14 is configured so that distal tip 24 contacts, and is substantially perpendicular, to tissue fold F at contact point P2. As illustrated in FIG. 3E, once tissue fold F is stretched across distal tip 24 of flexible tube 14, sharpened needle or obturator 34 may be extended from distal tip 24 of flexible tube 14 to pierce all four layers of the tissue wall W. Sharpened needle or obturator 34 is inserted via inlet 35 to flexible tube 14 on handle 16 (see FIG. 1A).

As discussed above, the GI lumen comprises an inner mucosal layer, connective tissue, the muscularis layer and the serosa layer. To obtain a durable purchase, e.g., in performing a stomach reduction procedure, the staples or anchors used to achieve reduction of the GI lumen must engage at least the muscularis tissue layer, and more preferably, the serosa layer as well. Advantageously, stretching of tissue fold F across distal tip 24 permits an anchor to be ejected through both the muscularis and serosa layers, thus enabling durable gastrointestinal tissue approximation.

As depicted in FIG. 3E, after tissue fold F is stretched across distal tip 24 of flexible tube 14 to form contact point P2 with tissue wall W, needle 34 may be extended from distal tip 24 and through tissue fold F. Because needle 34 penetrates the tissue wall twice, it exits within the gastrointestinal lumen, thus reducing the potential for injury to surrounding organs. Once the needle has penetrated tissue fold F, an anchor assembly is ejected through distal tip 24 as described hereinbelow.

With respect to FIGS. 4A-4C, a first embodiment of an anchor assembly suitable for use with the apparatus of the present invention is described. Anchor assembly 36 comprises T-anchor assembly having distal rod 38 a and proximal rod 38 b connected by suture 39. The precise shape, size and materials of the anchors may vary for individual applications. In addition, the suture material also may vary for individual applications. By way of example, the suture material may consist of monofilament wire, multifilament wire or any other conventional suture material. Alternatively, suture 39 may comprise elastic material, e.g. a rubber band, to facilitate adjustment of the distance between the proximal and distal rods. Suture 39 extends through a pair of through-holes 40 in each rod, thereby forming a loop. Alternatively, suture 39 may be attached to the rods via an eyelet or using a suitable adhesive. Preferably, through-holes 40 are located near the center of the rods 38 a and 38 b.

Referring to FIG. 4B, rods 38 a and 38 b may be delivered through needle 34 (see FIG. 3E) using push rod 42. Push rod 42 is adapted to freely translate through flexible tube 14 and needle 34. Push rod 42 is preferably flexible, so that it may slide through bendable section 26 of flexible tube 14. In addition, push rod 42 may include notch 43 near its distal end to facilitate grasping and tensioning suture 39 after anchor delivery.

During anchor delivery, the longitudinal axis of distal rod 38 a is substantially parallel to the longitudinal axis of needle 34. However, once distal rod 38 a is ejected from needle 34, suture tension induces the rod to rotate approximately 90 degrees about its longitudinal axis, so that its longitudinal axis is substantially perpendicular to the longitudinal axis of needle 35. This rotation of distal rod 38 a prevents it from being pulled back through tissue wall W.

Referring to FIG. 4C, once rod 38 a is ejected on the distal side of fold F, needle 35 is retracted and push rod 42 is used to eject rod 38 b on the proximal side of tissue fold F. Like distal rod 38 a, tension in the suture causes proximal rod 38 b to rotate about 90 degrees once it is ejected from the needle. Notch 43 in push rod 42 then may be employed to tighten suture 39 by any of a variety of mechanisms. Alternatively, suture 39 may comprise an elastic material that dynamically tightens the rods against tissue fold F.

Referring now to FIG. 5A, according to other embodiments, the anchor assembly comprises a T-anchor assembly suitable to be disposed over obturator 50. More particularly, distal rod 38 a includes through-hole 51 dimensioned for the passage of obturator tip 52, and obturator 50 is translatably inserted through flexible tube 14 via inlet 35 of handle 16 (see FIG. 1A). Proximal rod 38 b may be a solid rod that does not include a through-hole for passage of obturator 50. Alternatively, proximal rod 38 b may include a through-hole for the passage of the obturator. Preferably, obturator tip 52 is sharpened to facilitate tissue penetration.

With respect to FIG. 5B, once rod 38 a is ejected on the distal side of fold F, it rotates into a position substantially parallel to tissue wall W and perpendicular to the longitudinal axis of the obturator. Obturator 50 then is retracted and proximal rod 38 b is ejected from flexible tube 14. More particularly, when flexible tube 14 is retracted from tissue wall W, proximal rod 38 b is pulled through distal tip 24. Proximal rod 38 b then rotates substantially 90 degrees as it is ejected from flexible tube 14 so that rod 38 b is urged against tissue wall W.

Referring to FIG. 6A, according to further embodiments, anchor assembly 55 comprises a T-anchor assembly similar to the embodiment depicted in FIG. 4A. However, anchor assembly 55 includes fine wire tether 56 that may be twisted to maintain the tension between rods 38 a and 38 b.

With respect to FIG. 6B, a method of delivering anchor assembly 55 is described. Initially, distal rod 38 a is delivered across both tissue walls using needle 34. The needle then is retracted to release distal rod 38 a so that it engages the tissue wall. Next, needle 34 is retracted to release proximal rod 38 b, so that it too rotates into engagement with the tissue wall. A proximal portion of the wire tether is captured by notch 43 of push rod 42 (see FIG. 4B), and the push rod is rotated to cause proximal rod 38 b to clamp down on the tissue fold. Because wire tether 56 is twisted by rotation of push rod 42, it maintains the desired force on the tissue walls.

Referring now to FIG. 7, a unidirectionally adjustable anchor assembly suitable for use with apparatus of the present invention is described. Anchor assembly 60 comprises distal anchor 62 and unidirectionally adjustable proximal anchor 64, which are connected by suture 39. Distal anchor 62 is translationally fixed with respect to suture 39. Such fixation may be achieved in a variety of ways. For example, as seen in FIG. 7A, distal anchor 62 may comprise a pair of through-holes 63, located near the center of anchor 62 and through which suture 39 is threaded and tied off at knot 65.

FIG. 7B provides alternative techniques for fixing the distal anchor. As seen in FIG. 7B(i), distal anchor 62 may comprise hollow tube T having opening O. A distal end of suture 39 is passed through opening O and formed into knot K, which is dimensioned such that it cannot pass through opening O, thereby fixing the distal anchor with respect to the suture. In order to facilitate formation of knot K, distal anchor 62 optionally may comprise distal opening DO, which is dimensioned such that knot K may pass therethrough. The distal end of suture 39 may be passed through distal opening DO, knotted, and then pulled back within hollow tube T of anchor 62 until it catches at opening O.

A drawback of the fixation technique described with respect to FIG. 7B(i) is a risk of suture 39 being torn or cut due to rubbing against opening O. In FIG. 7B(ii), hollow tube T comprises first end E to which is connected wire loop L, which may be formed, for example from a nickel-titanium alloy (“Nitinol”). Suture 39 passes through the wire loop before terminating at knot K. Knot K is dimensioned such that it cannot pass back through the wire loop. Wire loop L directs suture 39 through opening O, thereby reducing rubbing of the suture against the opening and reducing a risk of tearing or cutting of suture 39.

FIG. 7B(iii) provides yet another alternative technique for fixing the distal anchor with respect to the suture. Distal anchor 62 again comprises hollow tube T having opening O. Rod R is disposed within tube T, and the ends of the tube may be either closed or crimped to rod R, such that the rod is maintained within the tube. The distal end of suture 39 is threaded through opening O, around rod R, and back out opening O. The suture is then knotted at knot K, thereby fixing distal anchor 62 with respect to suture 39.

In addition to the techniques shown in FIGS. 7A and 7B, suture 39 alternatively may be fixed with respect to anchor 62 by other means, for example, via a knotted eyelet or via a suitable adhesive. Additional techniques will be apparent to those of skill in the art. While anchor 62 is illustratively shown as a rod- or T-type anchor, any of a variety of anchors, per se known, may be used as distal anchor 62. Exemplary anchors are described in co-pending U.S. patent application Ser. No. 10/612,170, filed Jul. 1, 2003, which is incorporated herein by reference in its entirety. Additional anchors are described hereinbelow with respect to FIG. 17.

Referring again to FIG. 7A, adjustable proximal anchor 64 comprises outer cylinder 66 having first end 67 a and second end 67 b, as well as first opening 68 a and second opening 68 b. First and second openings 68 are preferably disposed near the center of cylinder 66 and approximately 180 apart. Anchor 64 further comprises first flexible rod 70 a and second flexible rod 70 b, both of which are disposed within outer cylinder 66 and coupled to first and second ends 67 of cylinder 66. Rods 70 may be formed, for example, from Nitinol or from a polymer, and may be separated from one another by small gap G. As with the previous anchor assemblies, the precise shape, size and materials of the anchors and suture may vary as required for specific applications.

As best seen in FIG. 7C, suture 39 passes from distal anchor 62 through first opening 68 a of proximal anchor 64, around second flexible rod 70 b, around first flexible rod 70 a, between rods 70 a and 70 b, and out through second opening 68 b. This suture winding provides a unidirectional adjustment capability that allows a length L of suture 39 disposed between distal anchor 62 and proximal anchor 64 to be shortened. However, the suture winding precludes an increase in length L. FIG. 8 illustrate the mechanism of this unidirectional adjustment capability in greater detail. Optionally, suture 39 may be tied off proximal of anchor 64 at knot 69, thereby forming a proximal loop of suture to facilitate deployment and/or adjustment of anchor assembly 60.

In FIG. 8A, a proximally-directed force F1 is applied to suture 39 proximal of adjustable anchor 64, while anchor 64 is held stationary or is advanced distally. A portion of force F1 is transferred through suture 39 to second flexible rod 70 b, which causes rod 70 b to bow, thereby increasing gap G and allowing suture 39 to freely pass between rods 70 a and 70 b and through proximal anchor 64, facilitating unidirectional adjustment. When anchor 64 is held stationary while suture 39 is retracted proximally, distal anchor 62 retracts proximally towards anchor 64. Alternatively, when anchor 64 is advanced distally while suture 39 is retracted proximally, distal anchor 62 either remains stationary or retracts proximally towards proximal anchor 64, depending upon a degree of distal advancement of proximal anchor 64. Regardless, length L of suture 39 disposed between anchors 62 and 64 is decreased, thereby unidirectionally adjusting a distance between the anchors.

In FIG. 8B, a distally-directed force F2 is applied to suture 39 distal of adjustable anchor 64. Force F2 may be applied, for example, by tissue compressed between anchors 62 and 64. Compressed tissue stores energy in a manner similar to a compression spring and seeks to push anchors 62 and 64 apart after unidirectional tightening. Force F2 causes the loop of suture 39 around first and second rods 70 to tighten, thereby bowing both rods inward and closing gap G such that suture 39 is friction locked between first and second flexible rods 70. In this manner, the length L of suture between anchors 62 and 64 may be selectively decreased but cannot be increased.

As will be apparent to those of skill in the art, the magnitude of force required to unidirectionally adjust length L may be altered in a variety of ways. For example, a length, flexibility or diameter of rods 70 may be altered. Likewise, the elasticity or diameter of suture 39 may be altered. Initial gap G may be increased or decreased. Furtherstill, the materials used to form rods 70 and suture 39 may be changed to alter material properties, such as coefficients of friction, and/or rods 70 or suture 39 may comprise a lubricious coating. Additional methods for varying the magnitude of force, a few of which are described hereinbelow with respect to FIG. 9, will be apparent in view of this disclosure and are included in the present invention.

Referring now to FIG. 9, alternative anchors 64 are described. In FIG. 9A, flexible rods 70 of proximal adjustable anchor 64′ are rotated with respect to openings 68 (or vice versa). When utilizing the suture winding described in FIGS. 7 and 8, rotation of rods 70 up to 180 clockwise progressively increases friction when force is applied to anchors 62 and 64. The magnitude of the friction lock is increased when force is applied in the manner described with respect to FIG. 8B. However, friction is also increased when unidirectionally adjusting the length of suture between the proximal and distal anchors by applying force in the manner described with respect to FIG. 8A. Rotation of rods 70 more than about 180 clockwise would cause anchor 64′ to friction lock regardless of which direction force were applied to suture 39, thereby negating the unidirectional adjustment capability. Counterclockwise rotation of rods 70 with respect to openings 68 would initially reduce friction during force application to suture 39 in either direction. It is expected that counterclockwise rotation in excess of about 90 would eliminate the friction lock described in FIG. 8B and allow bidirectional adjustment. Continued counterclockwise rotation beyond about 450 would reverse the directions of friction lock and unidirectional adjustment, while counterclockwise rotation beyond about 720 would result in friction lock regardless of which direction force were applied to suture 39.

As discussed previously, openings 68 of cylinder 66 of anchor 64 are preferably disposed approximately 180 apart from one another. However, in order to increase the friction lock force without significantly increasing friction during unidirectional adjustment, first opening 68 a may be rotated counterclockwise with respect to second opening 68 b (or vice versa), as seen with anchor 64″ of FIG. 9B. In this manner, first opening 68 a is no longer in line with rods 70, while second opening 68 b remains in line with rods 70. When force F1 is applied to anchor 64″, second flexible rod 70 b is able to bow outward and increase gap G, thereby facilitating unidirectional adjustment. Likewise, when force F2 is applied to the anchor, gap G is closed more tightly upon suture 39, thereby increasing the friction lock force. If first opening 68 a alternatively were rotated clockwise with respect to the second opening, it is expected that the friction lock force would be decreased.

In FIG. 9C, proximal adjustable anchor 64′″ comprises an alternative suture winding. Suture 39 passes from distal anchor 62 through first opening 68 a of anchor 64′″, around second flexible rod 70 b, around first flexible rod 70 a, back around second flexible rod 70 b, between rods 70 a and 70 b, and out through second opening 68 b. As with the suture winding described with respect to anchor 64 of FIGS. 7 and 8, the suture winding illustrated in FIG. 9C provides a unidirectional adjustment capability that allows a length L of suture 39 disposed between distal anchor 62 and proximal anchor 64′″ to be shortened. However, this suture winding precludes an increase in length L. Additional unidirectionally adjustable suture windings will be apparent to those of skill in the art.

With reference to FIG. 10, an alternative unidirectionally adjustable anchor comprising three rods is described. Anchor assembly 80 comprises distal anchor 62 and proximal anchor 82. Unidirectionally adjustable proximal anchor 82 comprises outer cylinder 84 having first end 85 a and second end 85 b (not shown), as well as first opening 86 a and second opening 86 b. First and second openings 86 are preferably disposed near the center of cylinder 84 and approximately 180 apart. Anchor 82 further comprises first flexible rod 88 a, second flexible rod 88 b and third flexible rod 88 c, all of which are disposed within outer cylinder 66 and coupled to first and second ends 85 of cylinder 64. Rods 88 are separated from one another by gaps G1 and G2.

Suture 39 passes from distal anchor 62 through first opening 86 a of proximal anchor 82, around first rod 88 a, between first rod 88 a and second rod 88 b, between second rod 88 b and third rod 88 c, around third rod 88 c, back to and around first rod 88 a, and out through second opening 86 b. As seen in FIG. 10A, when force F1 is applied to suture 39, gaps G1 and G2 remain open, thereby facilitating unidirectional adjustment/shortening of length L of suture 39 disposed between distal anchor 62 and proximal anchor 82. As seen in FIG. 10B, when force F2 is applied to suture 39, gaps G1 and G2 close down upon suture 39, thereby forming a friction lock that precludes an increase in length L of suture 39.

Referring now to FIG. 11, an alternative three rod anchor assembly is described. The unidirectionally adjustable anchors described hereinabove with respect to FIGS. 7-10 all comprise rods disposed within a cylinder having openings for passage of a suture. The openings act to center the suture with respect to the rods and can be used to alter magnitudes of force applied during adjustment and friction locking, as discussed previously. However, such openings present a risk of tearing or cutting the suture as the suture slides through the openings.

As seen in FIG. 11, anchor assembly 90 comprises distal anchor 62 and proximal anchor 92. Unidirectionally adjustable proximal anchor 92 comprises first flexible rod 94 a and second flexible rod 94 b, as well as rigid rod 96, which is preferably larger in diameter than first and second rods 94. Flexible rods 94 are preferably fabricated from Nitinol or a polymer, while rigid rod 96 is preferably fabricated from stainless steel or a polymer. Alternative materials will be apparent to those of skill in the art.

Anchor 92 further comprises first outer cylinder 98 a and second outer cylinder 98 b, which are crimped to the ends of first and second rods 94, and rigid rod 96. As an alternative to crimping, first and second cylinders 98 may each comprise an end cap (not shown) to which the rods are coupled. First and second cylinders 94 do not span a central portion of anchor 92. Flexible rods 94 are separated from one another by gap G1, while rods 94 are separated from rigid rod 96 by gap G2.

Anchor 92 comprises three rods, but, unlike anchor 82 of FIG. 10, suture 39 is only wrapped around two of them to achieve unidirectional adjustment. As best seen in FIGS. 11B and 11C, the illustrative suture winding of anchor assembly 90 is similar to that described previously with respect to anchor assembly 60 of FIGS. 7 and 8. The break between first and second cylinders 98 acts to center suture 39 with respect to the rods, as seen in FIG. 11A, while rigid rod 96 acts to stiffen and reduce rotation of anchor 92 as it directs suture 39 about flexible rods 94.

Suture 39 passes from distal anchor 62 to proximal anchor 92, between rigid rod 96 and flexible rods 94, around second flexible rod 94 b, around first flexible rod 94 a, between rigid rod 96 and first flexible rod 94 a, between flexible rods 94 a and 94 b, and out. As seen in FIG. 11A, when force F1 is applied to suture 39, flexible rods 94 are forced apart and gap G1 widens while gap G2 remains substantially constant, thereby allowing unidirectional adjustment of length L of suture 39 disposed between distal anchor 62 and proximal anchor 92. As seen in FIG. 11B, when force F2 is applied to suture 39, gap G1 closes down upon suture 39, thereby forming a friction lock that precludes an increase in length L of suture 39. Gap G2 again remains substantially constant.

With reference to FIG. 12, an alternative unidirectionally adjustable anchor assembly comprising pivots is described. Anchor assembly 100 comprises distal anchor 62 and proximal anchor 102. Unidirectionally adjustable proximal anchor 102 comprises outer cylinder 103 having first end 104 a and second end 104 b (not shown), as well as first opening 105 a and second opening 105 b. First and second openings 105 are preferably disposed near the center of cylinder 103 and approximately 180 apart. Anchor 102 further comprises first rod or paddle 106 a and second rod or paddle 106 b, both of which are disposed within outer cylinder 103 and coupled to the first and second ends of cylinder 103 by pins 107, which pass through pivot holes 108. In this manner, first and second paddles 106 are able to rotate about pivot holes 108. Paddles 106 may be formed, for example, from stainless steel or a polymer, and are separated from one another by gap G. As with the previous anchor assemblies, the precise shape, size and materials of the anchors, as well as suture 39, may vary as required for specific applications.

Suture 39 illustratively passes from distal anchor 62 through first opening 105 a of proximal anchor 102, around second paddle 106 b, around first paddle 106 a, between paddles 106 a and 106 b, and out through second opening 105 b. The placement of pivot holes 108 ensures that application of force F1, as described hereinabove, causes paddles 106 to rotate apart from one another and expand gap G, thereby enabling unidirectional adjustment. Likewise, application of previously discussed force F2 causes paddles 106 to rotate together, thereby closing gap G and pinching suture 39 between the paddles in a friction lock. An increase in the magnitude of force F2 serves to rotate paddles 106 together more tightly, thereby increasing the magnitude of the friction lock acting upon suture 39 between the paddles. In this manner, unidirectional adjustment is achieved.

Referring now to FIG. 13, an alternative unidirectionally adjustable anchor assembly comprising spring material is described. Anchor assembly 110 comprises distal anchor 62 and proximal anchor 112. Unidirectionally adjustable proximal anchor 112 comprises outer cylinder 113 having first end 114 a and second end 114 b (not shown), as well as first opening 115 a and second opening 115 b. First and second openings 115 are preferably disposed near the center of cylinder 113 and approximately 180 apart. Anchor 112 further comprises first rod 116 a and second rod 116 b that are separated by gap G, as well as spring material 118, all of which are disposed within outer cylinder 113. Spring material 118 abuts rods 116, which preferably are substantially the same length as cylinder 113, and may either move freely within cylinder 113 or may be coupled to the ends (not shown) of cylinder 113. Spring material 118 may also move freely within cylinder 113 or may be coupled to the cylinder, and comprises lumen 119 having a diameter that is preferably equal to or less than the diameter of suture 39. Spring material 118 may comprise, for example, a compressible biocompatible foam, which acts as a compression spring.

Suture 39 passes from distal anchor 62 to proximal anchor 112 through first opening 115 a of cylinder 113, between rods 116, through lumen 119 of spring material 118, and out through second opening 115 b. Lumen 119 snugly contacts suture 39 such that application of force F1 causes friction between the suture and the spring material to compress the spring material against the wall of cylinder 114, thereby reducing a stress applied to rods 116 by spring material 118 and increasing gap G such that unidirectional adjustment of length L of suture 39 disposed between distal anchor 62 and proximal anchor 102 may proceed. Application of force F2 stretches spring material 118 against rods 116, thereby increasing the stress applied to the rods by the spring material and closing gap G such that suture 39 is friction locked between rods 116.

With reference to FIG. 14, alternative unidirectionally adjustable anchor assemblies comprising one-way valves are described. In FIG. 14A, anchor assembly 120 comprises distal anchor 62 and proximal anchor 122. Unidirectionally adjustable proximal anchor 122 comprises outer cylinder 124 having first and second ends 125 a and 125 b, as well as first opening 126 a and second opening 126 b. First and second openings 126 are preferably disposed near the center of cylinder 124 and approximately 180 apart. Anchor 122 further comprises first inclined plane 128 a and second inclined plane 128 b, which are forced into apposition by compression springs 129 a and 129 b, thereby forming one-way valve V at the junction of the two inclined planes. Inclined planes 128 and springs 129 are disposed within outer cylinder 124; springs 129 abut ends 125 of cylinder 124, as well as the ends of the inclined planes. Suture 39′ comprises a plurality of knots or beads B adapted to actuate one-way valve V.

Suture 39′ passes from distal anchor 62 to proximal anchor 122 through first opening 126 a of cylinder 124, between inclined planes 128, through one-way valve V, and out through second opening 126 b. Application of force F1 to suture 39′ causes a bead B to contact inclined planes 128 and gradually coax them apart by compressing springs 129, thereby opening valve V and allowing the bead to pass through the valve. Once the bead has passed through valve V, springs 129 force inclined planes 128 back into apposition, thereby closing the valve. Continued application of force F1 allows multiple beads to pass through the valve, which facilitates unidirectional adjustment of suture length L disposed between distal anchor 62 and proximal anchor 122. Application of force F2 causes a bead B of suture 39′ to impinge upon the proximal sides of inclined planes 128. However, force transferred to the planes by the bead is perpendicular to the direction required to compress springs 129 and urge planes 128 apart. As such, the bead B impinging upon the proximal sides of planes 128 is not able to open one-way valve V and pass back through the valve in a distal direction, thereby ensuring only unidirectional adjustment, i.e. shortening, of the length L of suture disposed between the proximal and distal anchors.

In FIG. 14B, an alternative unidirectionally adjustable anchor having a one-way valve is described. Anchor assembly 130 comprises distal anchor 62 and proximal anchor 132. Unidirectionally adjustable proximal anchor 132 comprises lumen 134 having cantilevered inclined plane 136 disposed therein, which forms one-way valve V. ‘Zip-tie’ fastener 138, having a plurality of inclined planes 139, connects proximal anchor 132 and distal anchor 62. The plurality of inclined planes 139 are disposed about 180 out of phase with inclined plane 136 of anchor 132.

Fastener 138 passes from distal anchor 62 to proximal anchor 132, through lumen 134 and past inclined plane 136. Inclined planes 139 of fastener 138 mesh with inclined plane 136 and bend or cantilever plane 136, such that planes 139 of fastener 138 may proximally pass one-way valve V when force F1 is applied to the fastener, thereby enabling unidirectional adjustment of length L of fastener 138 disposed between the proximal and distal anchors. Conversely, when force F2 is applied to the fastener, the proximal side of inclined plane 136 of anchor 132 abuts the distal side of an inclined plane 139 of fastener 138, and the fastener cannot be drawn distally through proximal anchor 132, nor can the length L of fastener disposed between the anchors be increased significantly.

Referring now to FIG. 15, alternative unidirectionally adjustable anchor assemblies comprising a slipknot are described. In FIG. 15A, anchor assembly 140 comprises distal anchor 142 and proximal anchor 144. Through-holes 143 a and 143 b extend through distal anchor 142, while through-holes 145 a and 145 b extend through proximal anchor 145. Preferably, through-holes 143 and 145 are located near the center of anchors 142 and 144, respectively.

The distal end of suture 39 passes through through-hole 145 a of proximal anchor 144 to distal anchor 142, where it passes through through-hole 143 a and back through through-hole 143 b. It then extends from distal anchor 142 back to proximal anchor 144, where it passes through through-hole 145 b of the proximal anchor. The distal end of suture 39 is tied off at unidirectional slipknot S, which is located proximal of anchor 144. FIG. 15B provides a detail view illustrating formation of slipknot S.

As will be apparent to those of skill in the art, application of force F1 causes suture 39 to slide through through-holes 143 and 145, and decrease the length L of suture 39 disposed between anchors 142 and 144. Suture 39 may readily pass through slipknot S in a proximal direction, thereby facilitating unidirectional adjustment of length L. However, application of force F2 tightens slipknot S and prohibits passage of suture 39 through the slipknot in a distal direction, thereby precluding an increase in length L.

FIG. 15C illustrates an alternative embodiment of anchor assembly 140 wherein the slipknot is disposed within the proximal anchor. Anchor assembly 140′ comprises distal anchor 142 and proximal anchor 144′. Proximal anchor 144′ comprises hollow cylinder or tube 146 having distal openings 147 a and 147 b, and proximal opening 148.

The distal end of suture 39 passes through proximal opening 148 into the interior of tube 146. It then passes through distal opening 147 a of proximal anchor 144′ to distal anchor 142, where it passes through through-hole 143 a and back through through-hole 143 b. Next, suture 39 extends from distal anchor 142 back to proximal anchor 144′, where it passes through distal opening 147 b into the interior of tube 146 of the proximal anchor. The distal end of suture 39 is tied off at unidirectional slipknot S, which is disposed within tube 146 of anchor 144′. Anchor assembly 140′ may be unidirectionally adjusted in a manner similar to that described hereinabove with respect to anchor assembly 140 of FIG. 15A.

FIGS. 7-15 illustrate anchor assemblies comprising various mechanisms for achieving unidirectional adjustment of the distance between the proximal and distal anchors. These mechanisms have been provided solely for the sake of illustration and should in no way be construed as limiting. Additional mechanisms for achieving unidirectional adjustment will be apparent to those of skill in the art in view of this disclosure and are included in the present invention. Furthermore, a majority of the anchor assemblies of FIGS. 7-15 have been described with the distal anchor being fixed relative to the suture, and the proximal anchor being adjustable. However, it should be understood that the distal anchor may alternatively be adjustable and the proximal anchor may be fixed, and/or both anchors may be unidirectionally adjustable, as with anchor assembly 140 of FIG. 15.

With reference now to FIG. 16, a bi-directionally adjustable anchor assembly comprising a locking mechanism is described. Anchor assembly 150 comprises distal anchor 62 and proximal anchor 152. As seen in FIG. 16A, bi-directionally adjustable proximal anchor 152 comprises outer cylinder 153 having first end 154 a and second end 154 b, as well as first opening 155 a and second opening 155 b. First and second openings 155 are preferably disposed near the center of cylinder 153 and approximately 90 apart. Proximal anchor 152 further comprises tension spring 158 disposed within outer cylinder 153.

As seen in FIG. 16B, suture 39 passes from distal anchor 62 to proximal anchor 152 through first opening 155 a, around spring 158, and out through second opening 155 b. Suture 39 moves freely about tension spring 158 in either direction during application of force F1 or force F2, thereby facilitating bi-directional adjustment of suture length L disposed between the proximal and distal anchors. However, as seen in FIG. 16C, simultaneous application of forces F1 and F2 with sufficient magnitude causes suture 39 to force threads T of spring 158 apart, such that suture 39 is trapped between threads T and locked in position, thereby precluding further adjustment of suture length L.

The magnitude of forces required to actuate the locking mechanism of proximal anchor 152 and lock suture 39 within threads T of spring 158 may be specified/altered in a variety of ways. For example, the angular spacing of openings 155 about outer cylinder 153 may be altered, the spring constant of spring 158 may be specified, and/or spring 158 or suture 39 may comprise a lubricious coating. Additional techniques will be apparent to those of skill in the art. It is expected that simultaneous application of forces F1 and F2 will be encountered when anchor assembly 150 has been deployed across a tissue fold and suture length L has been adjusted such that the tissue fold is compressed. A medical practitioner would then apply force F1, while the compressed tissue fold would apply force F2.

Although the anchor assemblies of FIGS. 10-16 have illustratively been described without knots or loops of suture or fastener disposed proximal of the proximal anchor (as seen, for example, with knot 69 on suture 39 of anchor assembly 60 in FIGS. 7 and 8) it should be understood that such loops or knots optionally may be provided in order to facilitate deployment and/or adjustment of the anchor assemblies. Additionally, the previously described anchor assemblies illustratively comprise distal rod- or T-type anchors. However, it should be understood that distal T-anchors have only been provided for the sake of illustration. The distal anchors (as well as the proximal anchors) may comprise any of a variety of anchors, per se known. Exemplary anchors are described in co-pending U.S. patent application Ser. No. 10/612,170, filed Jul. 1, 2003, which is incorporated herein by reference in its entirety. Additional anchors are described hereinbelow with respect to FIG. 17.

Referring to FIG. 17A, articulating anchor 160 includes semi-cylindrical base 161, rod 162 and suture 39. Rod 162 rotates about pivot point 163 (as indicated by arrow 164) between an expanded position (shown in FIG. 7A) and a reduced profile position, wherein rod 162 pivots within the semi-cylindrical base 161. Articulating anchor 160 may be delivered through a tissue fold using needle 34 described hereinabove with respect to FIG. 3E. Preferably, articulating anchor 160 is biased in the expanded position so that it automatically expands once it is ejected from the needle.

With respect to FIGS. 17B and 17C the anchors of the present invention also may comprise one or more oblong bodies connected by at least one suture. In FIG. 17B, anchor 165 comprises elliptical ring 166 having sutures 39 attached at substantially opposite sides of the ring. In FIG. 17C, anchor 168 comprises angle bracket 169 having a pair of through-holes 170 for suture 39. In FIG. 17D, anchor 171 comprises oblong bead 172 having a pair of through-holes 173 for suture 39. All three anchors 165, 168 and 171 (as well as the T-anchors described previously) have a first dimension (e.g., width) that is substantially larger than a second dimension (e.g., height). This dimensional difference necessitates that anchors 165, 168 and 171 be inserted within needle (e.g., needle 34 of FIG. 3E) in a particular orientation. Once the anchor is ejected through a tissue wall, tension on suture 39 forces the anchor to rotate so that it cannot be pulled back through the tissue wall. As will be understood by those of skill in the art, numerous other anchors may be employed without departing from the scope of the present invention.

Referring now to FIG. 18A, an alternative embodiment of apparatus for forming a tissue fold, constructed in accordance with the principles of the present invention, is described. Apparatus 175 comprises treadmill assembly 176 disposed at distal tip 174 of flexible tube 177. Flexible tube 177 is configured to be inserted through a patient's mouth, esophagus and into the stomach. Treadmill assembly 176 comprises conveyor 180 that circles around a pair of hubs 181 a and 181 b. Hubs 181 a and 181 b rotate about axles 182 a and 182 b, respectively, and are interconnected by bracket 183. A plurality of barbs or needles 185 is disposed at substantially regular intervals around the circumference of conveyor 180.

Flexible tube 177 preferably includes a plurality of through-wall slots 186 to enhance flexibility of the tube, yet maintain torqueability. Preferably, flexible tube 177 is made from stainless steel with an etched or laser-cut slot pattern. Preferably, the slot pattern is a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of the tube.

Referring to FIGS. 18 and 19, transmission of motive force to treadmill assembly 176 is described. In particular, drive shaft 202 disposed within flexible tube 177 is coupled to a manual knob or motor located at the proximal end of the catheter. The distal tip of drive shaft 202 is provided with beveled gear 203 that meshes with beveled gear 204 provided on axle 182 b. Accordingly, rotation of beveled gear 203 is transmitted to beveled gear 204, thereby causing axle 182 b to rotate. Axle 182 b in turn rotates hub 181 b, actuating conveyor 180. Reversing the rotation of drive shaft 202 reverses the direction of conveyor 180.

Referring again to FIGS. 18A-18D, a method of forming a gastrointestinal tissue fold F using apparatus 175 is described. In FIG. 18A, flexible tube 177 is positioned transesophageally so that treadmill assembly 176 contacts tissue wall W. Preferably, contact should be made at an angle relative to the tissue wall W. For example, an angle of approximately 45 degrees is depicted in FIG. 8A, while many other angles may be used without departing from the scope of the present invention.

When treadmill assembly 176 contacts tissue wall W, needle 185 engages the tissue at contact point P1 as the needle moves around distal hub 181 a. As depicted in FIG. 18B, as the needle moves away from distal hub 181 a, tissue wall W is pulled towards proximal end 181 b, thereby forming a small tissue fold F. As the treadmill assembly continues to turn, subsequent needles 185 engage the tissue wall so that it becomes securely engaged to treadmill assembly 176 along the length of conveyor 180.

As depicted in FIG. 18C, once tissue wall W is securely engaged to treadmill assembly 176, distal end 174 of flexible tube 177 may be articulated in bendable section 190, thereby moving treadmill assembly 176 away from tissue wall W. The articulation of flexible tube 177 may be accomplished using a control wire and actuator disposed at the proximal end of the catheter, as previously described with respect to the embodiment of FIG. 1. By moving the treadmill assembly away from tissue wall W, additional tissue is pulled proximally and tissue fold F becomes elongated.

In FIG. 18D, tissue fold F is stretched across bendable section 190 of flexible tube 177 to create contact point P2. This permits a sharpened needle or obturator to be extended through one of slots 186 of bendable section 190 and across all four layers of the tissue wall W. Advantageously, stretching of tissue fold F across bendable section 190 permits an anchor to be ejected through both the muscularis and serosa layers, thus providing a durable foundation for gastrointestinal tissue approximation. For example, needle 192 may be extended through slot 186 in bendable section 190, and through the base of tissue fold F, and an anchor assembly (such as described with respect to any of FIGS. 4-17) may be ejected from needle 192 to secure the fold. Alternatively, an obturator (such as described with respect to FIGS. 5A and 5B) may be used to pierce the tissue fold at contact point P2 and deliver the anchor assembly. Treadmill assembly 176 may be disengaged from tissue wall W by reversing the rotation of proximal hub 181 b.

Referring now to FIG. 20A, a further alternative embodiment of apparatus for forming a tissue fold in accordance with the principles of the present invention is described. Apparatus 200 comprises tissue grabbing assembly 18′ coupled to the distal end of a flexible tube 177′, such as described with respect to the embodiment of FIG. 18. Flexible tube 177′ preferably includes a plurality of through-wall slots 186′ to enhance flexibility of the tube, yet maintain torqueability. In addition, flexible tube 177′ may be made from stainless steel with an etched or laser-cut slot pattern, such as a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of the tube.

Tissue grabbing assembly 18′ is similar to that described with respect to the embodiment of FIG. 1, and comprises a pair of jaws 28 a′, 28 b′ arranged to rotate about pivot point 29′ between an open configuration and a closed configuration. Each of jaws 28 a′, 28 b′ preferably includes sharpened teeth 33′ disposed near its distal end to facilitate grasping tissue wall W.

With respect to FIG. 20A, tissue grabbing assembly 18′ is positioned transesophageally adjacent to tissue wall W and jaws 28 a′, 28 b′ are moved to the open position. Tissue grabbing assembly 18′ then is moved into contact with tissue wall W. As depicted in FIG. 20B, tissue grabbing assembly 18′ is used to grab the tissue wall at a first contact point P1. After capturing a portion of tissue wall W within jaws 28 a′, 28 b′, flexible tube 177′ is urged proximally to stretch tissue wall W and create tissue fold F.

Referring to FIG. 20C, once tissue fold F is formed, the distal end of flexible tube 177′ is articulated about bendable section 190′ to move tissue grabbing assembly 18′ away from tissue wall W. Articulation of flexible tube 177′ may be controlled using an actuator disposed at the proximal end of the catheter, thus causing tissue fold F to become elongated.

In FIG. 20D, tissue fold F is shown stretched across bendable section 190′ so that a sharpened needle or obturator may be extended from one of slots 186′ in bendable section 190′ and across all four layers of the tissue wall W. Needle 192′ then may be extended from slot 186′ in bendable section 190′ through contact point P2 and tissue fold F. An anchor assembly (e.g., as described with respect to any of FIGS. 4-17) then may be ejected from needle 192′ to secure the fold. Alternatively, an obturator (e.g., as described with respect to FIGS. 5A and 5B) may be used to pierce the tissue fold at contact point P2 and deliver the anchor assembly.

With reference now to FIG. 21, an anchor delivery system adapted for use with the adjustable anchor assemblies of FIGS. 7-17 is described. In FIG. 21, the anchor delivery system is illustratively shown in use with anchor assembly 60 of FIG. 7, but this should in no way be construed as limiting. Also, the delivery system of FIG. 21 may be used in conjunction with apparatus for forming a tissue fold, such as apparatus 10, 175 and 200 described previously, in order to anchor the tissue fold; or may be used for any other application, or in conjunction with any other apparatus, requiring delivery of an anchor assembly.

In FIG. 21A, a distal region of anchor delivery system 250 is disposed adjacent tissue fold F in tissue wall W. Anchor delivery system 250 comprises flexible delivery tube 252 having lumen 253. Flexible delivery tube 252 may be configured for insertion through a patient's mouth and esophagus into a gastrointestinal lumen, such as the stomach. Lumen 253 of delivery tube 252 preferably has a diameter of less than about 3 cm, and even more preferably has a diameter of about 2.5 cm. Flexible delivery tube 252 preferably includes a plurality of through-wall slots 254 to enhance flexibility of the tube, yet maintain torqueability. Slots 254 may form bendable section 255. Preferably, flexible delivery tube 252 is made from stainless steel with an etched or laser-cut slot pattern. The slot pattern is preferably a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of the tube.

Anchor delivery system 250 further comprises delivery needle 260. Needle 260 preferably has a length of less than 2 cm, and even more preferably has a length of about 1.5 cm. Needle 260 preferably comprises sharpened distal tip 262, lumen 264, slot 266 extending proximally from distal tip 262, and proximal eyelet 268.

Lumen 264 of needle 260 is dimensioned such that a distal anchor may be disposed therein. As discussed previously, anchor delivery system 250 is illustratively described in conjunction with anchor assembly 60 of FIG. 7. In FIG. 21A, distal anchor 62 is disposed within lumen 264 of needle 260. Suture 39 passes through slot 266 of the needle as the suture extends from distal anchor 62 to proximal anchor 64. Needle 260 preferably is disposed within lumen 253 of flexible delivery tube 252 distal of bendable section 255, while proximal anchor 64 preferably is disposed within delivery tube 252 proximal of bendable section 255.

In this arrangement, distal anchor 62 may be deployed through needle 260 while the bendable section is actuated or bent, e.g., when anchor delivery system 250 is used in conjunction with previously described plication apparatus. Proximal anchor 64 subsequently may be advanced through bendable section 255 after the bendable section has once again been straightened. The distance, or length, of suture 39 extending between distal anchor 62, which is disposed distal of the bendable section, and proximal anchor 64, which is disposed proximal of the bendable section, is preferably greater than or equal to about 2 cm, and is even more preferably greater than or equal to about 4 cm.

Needle 260 is proximally coupled to needle pushrod 270, which facilitates translation of the needle beyond a distal end of flexible delivery tube 252. Needle pushrod 270 extends to a control actuator disposed at a proximal end of anchor delivery system 250 (not shown). Pushrod 270 optionally may be spring-loaded (not shown), for example, to facilitate puncture of tissue wall W and passage of needle 260 through tissue fold F.

Anchor delivery system 250 further comprises anchor pushrod 280, which is removably disposed through eyelet 268 of needle 260, and is configured to eject distal anchor 62 from lumen 264 of needle 260. As with needle pushrod 270, anchor pushrod 280 extends to a control actuator disposed at a proximal end of anchor delivery system 250 (not shown). The actuators controlling pushrods 270 and 280 are preferably at least partially coupled so that relative motion between the two pushrods can be limited and/or eliminated, as needed. Pushrod 280 passes through the proximal loop of suture formed by knot 69 on suture 39, such that the suture loop is threaded between needle pushrod 270 and anchor pushrod 280. This facilitates unidirectional adjustment of the length of suture disposed between distal anchor 62 and proximal anchor 64, as described hereinbelow.

In FIG. 21B, pushrods 270 and 280 are simultaneously distally advanced with sufficient force, e.g., via spring-loading, such that sharpened distal tip 262 of needle 260 pierces tissue wall W and is advanced across fold F. Bendable section 255 of flexible delivery tube 252 optionally may be bent during advancement of the needle, as described previously with respect to the plication apparatus (see FIG. 3E). Anchor pushrod 280 is then advanced distally with respect to needle pushrod 270 and needle 260, such that it abuts distal anchor 62 and ejects the anchor from lumen 264 of needle 260 on the distal side of tissue fold F, as seen in FIG. 21C. Suture 39 likewise is ejected from slot 266 and disposed across fold F.

During delivery, the longitudinal axis of distal anchor 62 is substantially parallel to the longitudinal axis of needle 260. However, once anchor 62 has been ejected from needle 260, suture tension induces the anchor to rotate approximately 90 about its longitudinal axis, so that its longitudinal axis is substantially perpendicular to the longitudinal axis of needle 260. This rotation of distal anchor 62 prevents it from being pulled back through tissue wall W. One or both ends of anchor 62 may be flared outward (not shown) to facilitate such rotation upon contact with the tissue wall.

In FIG. 21D, anchor pushrod 280 is retracted proximally within lumen 264 of needle 260, the needle is retracted within flexibly delivery tube 252 via pushrod 270, and then delivery system 250 is retracted proximally across tissue fold F. Distal anchor 62 is disposed on the distal side of the tissue fold, suture 39 extends through the fold, and proximal anchor 64 is disposed on the proximal side of the fold within delivery tube 252. If bendable section 255 were flexed during deployment of distal anchor 62 (see FIG. 3E), it is straightened to facilitate delivery of the proximal anchor.

Delivery tube 252 is then retracted proximally with respect to pushrods 270 and 280, causing needle 260 to exit lumen 253 of the delivery tube on the proximal side of tissue fold F, thereby providing space for proximal anchor 64 to exit the lumen. Next, delivery tube 252 or the full delivery system 250 is retracted, such that proximal anchor 64 is ejected from delivery tube lumen 253, as seen in FIG. 21E. Delivery tube 252 is then re-advanced and/or pushrods 270 and 280 are simultaneously retracted, such that needle 260 is repositioned within lumen 253 of the delivery tube.

Flexible delivery tube 252 is advanced with respect to needle 260, such that it pushes proximal anchor 64 distally. The proximal suture loop formed by knot 69 on suture 39 catches against the proximal end of needle 260 and anchor pushrod 280, which pulls distal anchor 62 taut against tissue fold F, as seen in FIG. 21F. Continued advancement of delivery tube 252 unidirectionally adjusts, i.e. shortens, length L of suture 39 disposed between distal anchor 62 and proximal anchor 64, while forcing proximal anchor 64 against the tissue fold and firmly anchoring the fold between the proximal and distal anchors.

Once length L has been adjusted such that anchor assembly 60 firmly anchors tissue fold F in position, anchor pushrod 280 may be retracted proximally with respect to needle pushrod 270 and needle 260, such that the distal end of anchor pushrod 280 is proximally retracted through eyelet 268 and out of needle 260. As seen in FIG. 21G, the suture loop formed by knot 69 on suture 39 slips off the distal end of anchor pushrod 280, removing anchor assembly 60 from anchor delivery system 250 and allowing the anchor delivery system to be removed from the patient.

Delivery system 250 optionally may comprise cutting apparatus (not shown) for removing the portion of suture extending proximally of proximal anchor 64 post-adjustment. Alternatively, secondary apparatus may be provided to remove such proximal length of suture. As yet another alternative, the unneeded length of suture may be left within the patient post-procedure.

In order to decrease the number of steps required to deliver and adjust anchor assembly 60, once distal anchor 62 has been deployed, as in FIG. 21C, the entire anchor delivery system 250 may be retracted proximally, such that needle 260 is retracted across tissue fold F while still disposed outside of delivery tube lumen 253. This is in contrast to the method described with respect to FIG. 21D, wherein the needle is disposed within the delivery tube prior to retraction across the tissue fold. Continued proximal retraction of anchor delivery system 250 or delivery tube 252 deploys proximal anchor 64 from delivery tube lumen 253. Anchor assembly 60 then may be unidirectionally adjusted, as described previously.

As will be apparent to those of skill in the art, when anchor delivery system 250 is used in conjunction with previously described apparatus 10, 175 or 200, to place an anchor assembly across fold F formed by said apparatus, flexible delivery tube 252 may either comprise or be advanced through flexible tube 14, 177 or 177′, of apparatus 10, 175 or 200, respectively. Likewise needle 260 may comprise needle 34, 92 or 92′, of apparatus 10, 175 or 200, respectively. Needle 260 may alternatively comprise obturator 50 of FIG. 5.

Referring now to FIG. 22, an alternative anchor delivery system is described. As with anchor delivery system 250 of FIG. 21, anchor delivery system 300 of FIG. 22 is adapted for use with the adjustable anchor assemblies of FIGS. 7-17. In FIG. 22, the anchor delivery system 300 is illustratively shown in use with anchor assembly 60 of FIG. 7, but this should in no way be construed as limiting. Also, delivery system 300 may be used in conjunction with apparatus for forming a tissue fold, such as apparatus 10, 175 and 200 described previously, in order to anchor the tissue fold; or may be used for any other application, or in conjunction with any other apparatus, requiring delivery of an anchor assembly.

FIG. 22A illustrates a distal region of anchor delivery system 300. System 300 comprises flexible delivery tube 302 having lumen 303. Flexible delivery tube 302 may be configured for insertion through a patient's mouth and esophagus into a gastrointestinal lumen, such as the stomach. Flexible delivery tube 302 preferably includes a plurality of through-wall slots 304 to enhance flexibility of the tube, yet maintain torqueability. Slots 304 may form bendable section 305. Preferably, flexible delivery tube 302 is made from stainless steel with an etched or laser-cut slot pattern. The slot pattern is preferably a sinusoidal repeating pattern of slots perpendicular to the longitudinal axis of the tube.

Flexible delivery tube 302 further comprises end region 306, which is coupled to anchor tube 307 having lumen or bore 308. As best seen in FIG. 22B, lumen 308 of anchor tube 307 communicates with lumen 303 of delivery tube 302 via through-slot 309. Proximal anchor 64 is disposed within anchor tube 307, while distal anchor 62 is disposed within needle 260′, which sits within delivery tube 302.

Suture 39 passes out of needle 260′ from distal anchor 62 through slot 266′. It then crosses from flexible delivery tube 302 to anchor tube 307 via through-slot 309. After passing through proximal anchor 64, suture 39 is passed back to delivery tube 302 via the through-slot, and is threaded around anchor pushrod 280′, such that the loop of suture formed by knot 69 on suture 39 is disposed between needle pushrod 270′ and anchor pushrod 280′.

Needle 260′, needle pushrod 270′ and anchor pushrod 280′ are substantially the same as needle 260 and pushrods 270 and 280, respectively, which are described hereinabove with respect to anchor delivery system 250 of FIG. 21. Furthermore, anchor assembly 60 may be delivered from and adjusted by anchor delivery system 300 in a manner similar to that described hereinabove with respect to system 250.

In FIG. 22A, anchor tube 307 of anchor delivery system 300 is illustratively shown as a relatively short tube having lumen or bore 308 adapted for disposal of proximal anchor 64 therein. However, it should be understood that anchor tube 307, lumen 308 and/or through-slot 309 alternatively may extend all or part of the way to a proximal end of flexible delivery tube 302 of delivery system 300. Advantageously, such an arrangement facilitates loading of anchor assembly 60 from a proximal end of the anchor delivery system and may simplify manufacturing of the system.

Anchor delivery system 300 illustratively has been described with a single anchor assembly 60 disposed therein. However, it should be understood that a plurality of anchor assemblies may be loaded within delivery system 300, thereby facilitating delivery of multiple anchor assemblies across different points of a tissue fold, across different (e.g., adjacent) tissue folds, or across other tissue structures. The plurality of distal anchors 62 preferably are loaded within needle 262′ of flexible delivery tube 302, while the plurality of proximal anchors 64 preferably are loaded within lumen 308 of anchor tube 307.

An advantage of anchor delivery system 300, as compared to system 250 of FIG. 21, is that both the proximal and distal anchors are located distal of the bendable section of the delivery tube during delivery. This reduces an initial length of suture that must be disposed between the anchors, thereby reducing a length of unneeded suture extending proximally of the proximal anchor post-delivery and adjustment. It also simplifies delivery by allowing both the proximal and distal anchors to be delivered while the bendable section of the delivery tube is bent. Additionally, placement of the proximal anchor in a separate anchor tube eliminates a need to eject the needle from the flexible delivery tube on the proximal side of a tissue fold in order to deploy the proximal anchor, thereby reducing a risk of accidental tissue puncture with the needle.

With reference to FIG. 23, another alternative anchor delivery system is described. As with anchor delivery systems 250 and 300 of FIGS. 21 and 22, respectively, anchor delivery system 400 of FIG. 23 is adapted for use with the adjustable anchor assemblies of FIGS. 7-17. Anchor delivery system 400 is illustratively shown in use with anchor assembly 60 of FIG. 7, but this should in no way be construed as limiting. Also, delivery system 400 may be used in conjunction with apparatus for forming a tissue fold, such as apparatus 10, 175 and 200 described previously, in order to anchor the tissue fold; or may be used for any other application, or in conjunction with any other apparatus, requiring delivery of an anchor assembly.

FIG. 23 illustrates a distal region of anchor delivery system 400. System 400 comprises flexible delivery tube 402 having lumen 403. Flexible delivery tube 402 may be configured for insertion through a patient's mouth and esophagus into a gastrointestinal lumen, such as the stomach. Flexible delivery tube 402 preferably includes a plurality of through-wall slots to enhance flexibility of the tube, yet maintain torqueability. The slots may form bendable section 405.

Anchor delivery system 400 further comprises delivery needle 260″, which is disposed within lumen 403 of flexible delivery tube 402 distal of bendable section 405 during delivery. As discussed previously, anchor delivery system 400 is illustratively described in conjunction with anchor assembly 60 of FIG. 7. Needle 260″ preferably has a length sufficient for both distal anchor 62 and proximal anchor 64 of anchor assembly 60 to be disposed therein; for example, needle 260″ preferably has a length of less than about 5 cm, and even more preferably has a length of about 3 cm. Except for an increase in length, needle 260″ is substantially the same as needle 260 of FIG. 21.

In FIG. 23, both distal anchor 62 and proximal anchor 64 are disposed within lumen 264″ of needle 260″. Suture 39 passes through and back through slot 266″ of the needle as the suture extends from distal anchor 62 to proximal anchor 64. Alternatively the length of suture between the proximal and distal anchors may be disposed within the needle during delivery. Advantageously, both the proximal and distal anchors of anchor assembly 60 may be deployed through needle 260″ while bendable section 405 is actuated or bent, e.g., while anchor delivery system 400 is used in conjunction with previously described plication apparatus.

Needle 260″ is proximally coupled to flexible needle pushtube 420, which facilitates translation of the needle beyond a distal end of flexible delivery tube 402. As will be apparent to those of skill in the art, needle 260″ and needle pushtube 420 optionally may be manufactured as a single piece. Needle pushtube 420 comprises lumen 422, as well as skive 424 that communicates with lumen 422. Needle pushtube 420 extends to a control actuator (not shown), which may be spring-loaded, disposed at a proximal end of anchor delivery system 400.

Anchor pushrod 280″, which is substantially the same as anchor pushrod 280 described previously, is removably disposed within lumen 422 of needle pushtube 420 distal of skive 424. As with pushtube 420, anchor pushrod 280″ extends to a control actuator (not shown) disposed at a proximal end of the anchor delivery system. Suture 39 proximally extends from proximal anchor 64 through slot 266″ of needle 260″, through skive 424 and within lumen 422 of needle pushtube 420, around anchor pushrod 280″ and out through skive 424 to knot 69. The proximal loop of suture formed by knot 69 is trapped around pushrod 280″ and within lumen 422 of the needle pushtube, thereby facilitating unidirectional adjustment of the length of suture disposed between distal anchor 62 and proximal anchor 64. As an alternative to the proximal loop of suture, knot 69 may be formed on the proximal end of suture 39, such that the knot is trapped between anchor pushtube 280″ and needle pushrod 420 (see knot K of FIG. 24).

Anchor assembly 60 may be delivered from and adjusted by anchor delivery system 400 in a manner similar to that described hereinabove with respect to system 250 of FIG. 21, with a few alterations. Specifically, during deployment of distal anchor 62, anchor pushrod 280″ is advanced against proximal anchor 64, which in turn advances in-line distal anchor 62. The pushrod is advanced a sufficient distance with respect to needle 260″ to eject the distal anchor from needle lumen 264″, but not so far as to also prematurely eject proximal anchor 64. Motion limitation apparatus may be provided to ensure that the distal anchor is not prematurely ejected. Exemplary motion limitation apparatus is described hereinbelow with respect to FIG. 24; additional apparatus, per se known, will be apparent.

In order to eject proximal anchor 64 from lumen 264″ of needle 260″, either the needle is retracted until length L of suture 39 disposed between the proximal and distal anchors is pulled taut and pulls the proximal anchor out of the needle lumen, or anchor pushrod 280″ is advanced a sufficient distance within the lumen of needle 260″ to eject the proximal anchor from the lumen (or a combination thereof). Additionally, in order to release anchor assembly 60 from anchor delivery system 400 post-delivery and adjustment, anchor pushrod 280″ is retracted proximal of skive 424 such that the loop of suture 39 formed by knot 69 is no longer trapped within lumen 422 of needle pushrod 420.

A significant advantage of anchor delivery system 400, as compared to system 250 of FIG. 21, is that both the proximal and distal anchors are disposed distal of bendable section 405 of flexible delivery tube 402. A significant advantage of anchor delivery system 400, as compared to system 300 of FIG. 22, is that both the proximal and distal anchors are disposed within needle 260″, thereby eliminating a need for an anchor tube and reducing the profile of the system.

Referring now to FIG. 24, an alternative embodiment of anchor delivery system 400 is described comprising motion limitation apparatus. Anchor delivery system 400′ is substantially the same as system 400, except that needle pushrod 420′ comprises two skives: motion limitation skive 430 and unidirectional adjustment skive 432, both of which communicate with lumen 422′ of the needle pushrod. Suture 39 proximally extends from proximal anchor 64, through motion limitation skive 430 and within lumen 422′ between anchor pushrod 280″ and needle pushtube 420′. Suture 39 exits skive 430 and is tied off at motion limitation knot K, which is trapped at skive 430 by anchor pushrod 280″. Suture 39 then continues proximally to unidirectional adjustment skive 432 and the proximal loop of suture formed by knot 69, which is trapped at skive 432 around pushrod 280″.

A length of suture extending between proximal anchor 64 and knot K is specified such that distal anchor 62 may exit lumen 264″ of needle 260″, but proximal anchor 64 cannot while knot K is trapped at skive 430 by anchor pushrod 280″. For example, during delivery of anchor assembly 60 across a tissue fold, advancement of pushrod 280″ advances proximal anchor 64, which in turn advances in-line distal anchor 62 until the distal anchor is ejected from needle lumen 264″ on the distal side of the tissue fold. Knot K limits a distance anchor pushrod 280″ may be advanced and ensures that proximal anchor 64 is not prematurely deployed.

Once anchor delivery system 400′ is again disposed on the proximal side of the tissue fold, anchor pushrod 280″ is retracted proximal of motion limitation skive 430, thereby allowing knot K to escape from skive 430 and facilitating deployment of proximal anchor 64. Proximal anchor 64 may be deployed by either retracting needle 260″ until the length of suture between the two anchors is pulled taut and pulls the proximal anchor out of the needle, or by re-advancing pushrod 280″ to push the proximal anchor out of the needle.

The anchor assembly may then be unidirectionally adjusted via the suture loop trapped at skive 232, as described previously. After adjustment has been completed, anchor pushrod 280″ is retracted proximal of unidirectional adjustment skive 432, thereby allowing the loop of suture formed by knot 69 of suture 39 to escape from skive 432. A significant advantage of anchor delivery system 400′, as compared to system 400 of FIG. 23, is that motion limitation skive 430 reduces a risk of premature deployment of proximal anchor 64.

Although preferred illustrative embodiments of the present invention are described hereinabove, it will be apparent to those skilled in the art that various changes and modifications may be made thereto without departing from the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2201610May 20, 1938May 21, 1940Dawson Jr James CWound clip
US2413142Jun 11, 1945Dec 24, 1946Edwin M JonesSuturing assembly and method
US3150379Mar 1, 1962Sep 29, 1964Ernest C WoodSingle clip disposable applicator
US3166072Oct 22, 1962Jan 19, 1965Jr John T SullivanBarbed clips
US3494006Jan 12, 1968Feb 10, 1970George C BrumlikSelf-gripping fastening device
US3551987Sep 12, 1968Jan 5, 1971Wilkinson Jack EStapling clamp for gastrointestinal surgery
US3646615Jan 26, 1970Mar 7, 1972Richard A NessReinforcing element for muscles
US3664345Jul 6, 1970May 23, 1972Clyde Harwell DabbsSurgical buttons
US3753438Apr 25, 1972Aug 21, 1973P SamuelsSuture clip
US3867944Oct 27, 1972Feb 25, 1975Wood Ernest CHemostatic clip and applicator therefor
US3874388Feb 12, 1973Apr 1, 1975Ochsner Med Found AltonShunt defect closure system
US3910281Oct 9, 1973Oct 7, 1975Bio Medicus IncSuture anchor
US3976079May 6, 1975Aug 24, 1976Samuels Peter BSecuring devices for sutures
US4007743Oct 20, 1975Feb 15, 1977American Hospital Supply CorporationOpening mechanism for umbrella-like intravascular shunt defect closure device
US4060089Sep 3, 1975Nov 29, 1977United States Surgical CorporationSurgical fastening method and device therefor
US4069825Jan 28, 1976Jan 24, 1978Taichiro AkiyamaSurgical thread and cutting apparatus for the same
US4235238 *May 4, 1979Nov 25, 1980Olympus Optical Co., Ltd.Apparatus for suturing coeliac tissues
US4245624Dec 30, 1977Jan 20, 1981Olympus Optical Co., Ltd.Endoscope with flexible tip control
US4367746Dec 8, 1980Jan 11, 1983Derechinsky Victor EClip-holder instrument for clipping blood vessels
US4414720Jul 22, 1982Nov 15, 1983Clarence CroomsCranial closure
US4462402Nov 15, 1982Jul 31, 1984Minnesota Mining And Manufacturing CompanyMethod and anchor for anchoring
US4494531Dec 6, 1982Jan 22, 1985Cook, IncorporatedExpandable blood clot filter
US4532926Jun 20, 1983Aug 6, 1985Ethicon, Inc.Two-piece tissue fastener with ratchet leg staple and sealable latching receiver
US4534350Jun 20, 1983Aug 13, 1985Ethicon, Inc.Two-piece tissue fastener with compressible leg staple and retaining receiver
US4548202Jun 20, 1983Oct 22, 1985Ethicon, Inc.Mesh tissue fasteners
US4586503Dec 1, 1983May 6, 1986University Of New MexicoSurgical microclip
US4592339Jun 12, 1985Jun 3, 1986Mentor CorporationGastric banding device
US4592356Sep 28, 1984Jun 3, 1986Pedro GutierrezLocalizing device
US4595007Mar 14, 1983Jun 17, 1986Ethicon, Inc.Split ring type tissue fastener
US4610250Oct 8, 1985Sep 9, 1986United States Surgical CorporationTwo-part surgical fastener for fascia wound approximation
US4669473Sep 6, 1985Jun 2, 1987Acufex Microsurgical, Inc.Surgical fastener
US4705040Nov 18, 1985Nov 10, 1987Medi-Tech, IncorporatedPercutaneous fixation of hollow organs
US4711002Jan 14, 1987Dec 8, 1987Pinckney Molded Plastics, Inc.Bag tie with press release lever
US4724840Feb 3, 1982Feb 16, 1988Ethicon, Inc.Surgical fastener applier with rotatable front housing and laterally extending curved needle for guiding a flexible pusher
US4750492Feb 27, 1985Jun 14, 1988Richards Medical CompanyAbsorbable suture apparatus, method and installer
US4765335May 6, 1987Aug 23, 1988Intermar, Inc.Aneurysm clip
US4832055Jul 8, 1988May 23, 1989Palestrant Aubrey MMechanically locking blood clot filter
US4841888Nov 19, 1987Jun 27, 1989Mills Timothy NSewing machine
US4873976Feb 28, 1984Oct 17, 1989Schreiber Saul NSurgical fasteners and method
US4890615Nov 5, 1987Jan 2, 1990Concept, Inc.Arthroscopic suturing instrument
US4923461Mar 22, 1989May 8, 1990Concept, Inc.Method of arthroscopic suturing of tissue
US4929240Dec 21, 1987May 29, 1990University Of New MexicoSurgical clip and applier
US4957498Nov 7, 1989Sep 18, 1990Concept, Inc.Suturing instrument
US5032127Mar 7, 1990Jul 16, 1991Frazee John GHemostatic clip and applicator therefor
US5035692Feb 13, 1990Jul 30, 1991Nicholas HerbertHemostasis clip applicator
US5037433May 17, 1990Aug 6, 1991Wilk Peter JEndoscopic suturing device and related method and suture
US5041129Jul 2, 1990Aug 20, 1991Acufex Microsurgical, Inc.Slotted suture anchor and method of anchoring a suture
US5059201Jan 22, 1991Oct 22, 1991Asnis Stanley ESuture threading, stitching and wrapping device for use in open and closed surgical procedures
US5073166Feb 15, 1989Dec 17, 1991Medical Innovations CorporationMethod and apparatus for emplacement of a gastrostomy catheter
US5088979Nov 2, 1990Feb 18, 1992Wilson-Cook Medical Inc.Method for esophageal invagination and devices useful therein
US5100418Dec 15, 1989Mar 31, 1992Inbae YoonSuture tie device system and applicator therefor
US5108420Feb 1, 1991Apr 28, 1992Temple UniversityAperture occlusion device
US5122136Mar 13, 1990Jun 16, 1992The Regents Of The University Of CaliforniaEndovascular electrolytically detachable guidewire tip for the electroformation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas
US5123914May 19, 1986Jun 23, 1992Cook IncorporatedVisceral anchor for visceral wall mobilization
US5201746Oct 16, 1991Apr 13, 1993United States Surgical CorporationSurgical hemostatic clip
US5203864Apr 5, 1991Apr 20, 1993Phillips Edward HSurgical fastener system
US5217471May 30, 1991Jun 8, 1993Burkhart Stephen SEndoscopic suture knotting instrument
US5217473Jun 25, 1991Jun 8, 1993Inbae YoonMulti-functional instruments and stretchable ligating and occluding devices
US5222508Oct 9, 1992Jun 29, 1993Osvaldo ContariniMethod for suturing punctures of the human body
US5222961Jan 8, 1992Jun 29, 1993Naomi NakaoEndoscopic stapling device and related staple
US5222963Jan 17, 1991Jun 29, 1993Ethicon, Inc.Pull-through circular anastomosic intraluminal stapler with absorbable fastener means
US5224946Apr 5, 1991Jul 6, 1993American Cyanamid CompanyBone anchor and method of anchoring a suture to a bone
US5234430Dec 18, 1991Aug 10, 1993Huebner Randall JOrthopedic fixation screw and method
US5234445Sep 18, 1992Aug 10, 1993Ethicon, Inc.Endoscopic suturing device
US5250053May 29, 1992Oct 5, 1993Linvatec CorporationSuture shuttle device
US5254126Jun 24, 1992Oct 19, 1993Ethicon, Inc.Endoscopic suture punch
US5261916Dec 12, 1991Nov 16, 1993Target TherapeuticsDetachable pusher-vasoocclusive coil assembly with interlocking ball and keyway coupling
US5268001Sep 25, 1991Dec 7, 1993Innovasive Devices, Inc.Bone fastener
US5269809 *Apr 5, 1991Dec 14, 1993American Cyanamid CompanyLocking mechanism for use with a slotted suture anchor
US5282827Mar 5, 1992Feb 1, 1994Kensey Nash CorporationHemostatic puncture closure system and method of use
US5284488Dec 23, 1992Feb 8, 1994Sideris Eleftherios BAdjustable devices for the occlusion of cardiac defects
US5304184Oct 19, 1992Apr 19, 1994Indiana University FoundationApparatus and method for positive closure of an internal tissue membrane opening
US5304195Jan 21, 1993Apr 19, 1994Target Therapeutics, Inc.Detachable pusher-vasoocclusive coil assembly with interlocking coupling
US5304204Feb 9, 1993Apr 19, 1994Ethicon, Inc.Receiverless surgical fasteners
US5316543Nov 27, 1990May 31, 1994Cook IncorporatedMedical apparatus and methods for treating sliding hiatal hernias
US5327914Sep 2, 1992Jul 12, 1994Shlain Leonard MMethod and devices for use in surgical gastroplastic procedure
US5330503Aug 13, 1992Jul 19, 1994Inbae YoonSpiral suture needle for joining tissue
US5334217May 14, 1993Aug 2, 1994Regents Of The University Of MinnesotaSeptal defect closure device
US5342376May 3, 1993Aug 30, 1994Dermagraphics, Inc.Inserting device for a barbed tissue connector
US5345949Aug 20, 1993Sep 13, 1994Shlain Leonard MMethods for use in surgical gastroplastic procedure
US5354298Feb 17, 1993Oct 11, 1994United States Surgical CorporationSuture anchor installation system
US5366459Sep 18, 1991Nov 22, 1994Inbae YoonSurgical clip and clip application procedures
US5366479Jul 30, 1993Nov 22, 1994United States Surgical CorporationSurgical staple for attaching an object to body tissue
US5372146Nov 6, 1990Dec 13, 1994Branch; Thomas P.Method and apparatus for re-approximating tissue
US5372604Jun 18, 1993Dec 13, 1994Linvatec CorporationSuture anchor for soft tissue fixation
US5374275Mar 25, 1993Dec 20, 1994Synvasive Technology, Inc.Surgical suturing device and method of use
US5380334May 6, 1993Jan 10, 1995Smith & Nephew Dyonics, Inc.Soft tissue anchors and systems for implantation
US5382231Feb 2, 1993Jan 17, 1995Shlain; Leonard M.Method for transesophageal retraction of the stomach
US5395030Jun 2, 1993Mar 7, 1995Olympus Optical Co., Ltd.Surgical device for stapling and fastening body tissues
US5403326Feb 1, 1993Apr 4, 1995The Regents Of The University Of CaliforniaMethod for performing a gastric wrap of the esophagus for use in the treatment of esophageal reflux
US5403329Mar 21, 1994Apr 4, 1995United States Surgical CorporationInstrument for closing trocar puncture wounds
US5417691Apr 15, 1993May 23, 1995Hayhurst; John O.Apparatus and method for manipulating and anchoring tissue
US5417699Dec 10, 1992May 23, 1995Perclose IncorporatedDevice and method for the percutaneous suturing of a vascular puncture site
US5425744Apr 18, 1994Jun 20, 1995C. R. Bard, Inc.Occluder for repair of cardiac and vascular defects
US5429598Apr 19, 1994Jul 4, 1995Applied Medical Resources CorporationSurgical access device and procedure
US5431666Feb 24, 1994Jul 11, 1995Lasersurge, Inc.Surgical suture instrument
US5433721Jul 15, 1993Jul 18, 1995Ethicon, Inc.Endoscopic instrument having a torsionally stiff drive shaft for applying fasteners to tissue
US5433727Aug 16, 1994Jul 18, 1995Sideris; Eleftherios B.Centering buttoned device for the occlusion of large defects for occluding
US5437680Jan 6, 1993Aug 1, 1995Yoon; InbaeSuturing method, apparatus and system for use in endoscopic procedures
US5437681Jan 13, 1994Aug 1, 1995Suturtek Inc.Suturing instrument with thread management
US5545178 *Oct 21, 1994Aug 13, 1996Kensey Nash CorporationSystem for closing a percutaneous puncture formed by a trocar to prevent tissue at the puncture from herniating
US6352503 *Jul 15, 1999Mar 5, 2002Olympus Optical Co., Ltd.Endoscopic surgery apparatus
US6669707 *Jan 24, 2000Dec 30, 2003Lee L. SwanstromMethod and apparatus for attaching or locking an implant to an anatomic vessel or hollow organ wall
US6699263 *Apr 5, 2002Mar 2, 2004Cook IncorporatedSliding suture anchor
USRE34021Nov 13, 1989Aug 4, 1992Abbott LaboratoriesPercutaneous fixation of hollow organs
Non-Patent Citations
Reference
1Angiolink, The Expanding Vascular Staple [brochure], 1 page total.
2Bluett et al., "Experimental Evaluation of Staple Lines in Gastric Surgery," Arch. Surg., vol. 122, (Jul. 1987), pp. 772-776.
3Brolin et al., Experimental Evaluation of Techniques of Gastric Paritioning for Morbid Obesity, Surgery, Gynecology & Obstetrics, vol. 153, (Dec. 1981), pp. 878-882.
4Chuttani et al., "A Novel Endoscopic Full-thickness Plicator for Treatment of GERD: An Animal Model Study," Gastrointestinal Endoscopy, vol. 26, No. 1,(2002), pp. 116-122.
5Johnston et al. "The Magenstrasse and Mill Operation of Morbid Obesity", Obesity Surgery 13, (2003), pp. 10-16.
6Okudaira et al., "The Healing and Tensile Strength of the Gastroplasty Staple Line," The American Surgeon, (Oct. 1984), pp. 564-568.
7Surgical Dynamics Inc., The S.D.sorb Meniscal Stapler [brochure] (1997), 3 pages total.
8Sutura, The Next Generation in Vascular Suturing Devices: SuperStitch [brochure], 2 pages total.
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7575548 *Aug 19, 2005Aug 18, 2009Olympus CorporationEndoscopic treatment instrument, endoscopic treatment system and supporting adaptor
US7645286Jan 12, 2010Neotract, Inc.Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US7708715 *Mar 21, 2005May 4, 2010Boston Scientific Scimed, Inc.Tissue approximation device
US7753936 *Jul 13, 2010Ehticon Endo-Surgery, Inc.Form in place fasteners
US7758594May 20, 2005Jul 20, 2010Neotract, Inc.Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US7766923Aug 3, 2010Neotract, Inc.Integrated handle assembly for anchor delivery system
US7780682Aug 3, 2007Aug 24, 2010Neotract, Inc.Apparatus and method for manipulating or retracting tissue and anatomical structure
US7815655Oct 19, 2010Neotract, Inc.Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US7896891Jul 24, 2006Mar 1, 2011Neotract, Inc.Apparatus and method for manipulating or retracting tissue and anatomical structure
US7905889Aug 13, 2007Mar 15, 2011Neotract, Inc.Integrated handle assembly for anchor delivery system
US7909836Jul 9, 2007Mar 22, 2011Neotract, Inc.Multi-actuating trigger anchor delivery system
US7914542Aug 13, 2007Mar 29, 2011Neotract, Inc.Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US7942884Jul 1, 2003May 17, 2011Usgi Medical, Inc.Methods for reduction of a gastric lumen
US7942898Jul 1, 2003May 17, 2011Usgi Medical, Inc.Delivery systems and methods for gastric reduction
US7946976May 24, 2011Michael GertnerMethods and devices for the surgical creation of satiety and biofeedback pathways
US7951158May 31, 2011Neotract, Inc.Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US7963907Jun 21, 2011Michael GertnerClosed loop gastric restriction devices and methods
US7976554Jul 12, 2011Vibrynt, Inc.Devices, tools and methods for performing minimally invasive abdominal surgical procedures
US8001974Aug 23, 2011Vibrynt, Inc.Devices and methods for treatment of obesity
US8007464 *Mar 31, 2010Aug 30, 2011Boston Scientific Scimed, Inc.Tissue approximation device
US8007503Aug 30, 2011Neotract, Inc.Apparatus and method for manipulating or retracting tissue and anatomical structure
US8029504Oct 4, 2011Ethicon Endo-Surgery, Inc.Electroporation ablation apparatus, system, and method
US8037591Feb 2, 2009Oct 18, 2011Ethicon Endo-Surgery, Inc.Surgical scissors
US8043309Oct 25, 2011Neotract, Inc.Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US8070673Dec 6, 2011Michael GertnerDevices and methods to treat a patient
US8070759May 30, 2008Dec 6, 2011Ethicon Endo-Surgery, Inc.Surgical fastening device
US8070768Apr 19, 2006Dec 6, 2011Vibrynt, Inc.Devices and methods for treatment of obesity
US8075572Apr 26, 2007Dec 13, 2011Ethicon Endo-Surgery, Inc.Surgical suturing apparatus
US8100922 *Apr 27, 2007Jan 24, 2012Ethicon Endo-Surgery, Inc.Curved needle suturing tool
US8114072May 30, 2008Feb 14, 2012Ethicon Endo-Surgery, Inc.Electrical ablation device
US8114119Sep 9, 2008Feb 14, 2012Ethicon Endo-Surgery, Inc.Surgical grasping device
US8157815Feb 6, 2007Apr 17, 2012Neotract, Inc.Integrated handle assembly for anchor delivery system
US8157834Apr 17, 2012Ethicon Endo-Surgery, Inc.Rotational coupling device for surgical instrument with flexible actuators
US8172772May 8, 2012Ethicon Endo-Surgery, Inc.Specimen retrieval device
US8187297May 29, 2012Vibsynt, Inc.Devices and methods for treatment of obesity
US8192455Jul 30, 2004Jun 5, 2012Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical CollegeCompressive device for percutaneous treatment of obesity
US8192461Sep 10, 2009Jun 5, 2012Cook Medical Technologies LlcMethods for facilitating closure of a bodily opening using one or more tacking devices
US8211118Jan 7, 2011Jul 3, 2012Neotract, Inc.Apparatus and method for manipulating or retracting tissue and anatomical structure
US8211125Aug 15, 2008Jul 3, 2012Ethicon Endo-Surgery, Inc.Sterile appliance delivery device for endoscopic procedures
US8216254Jul 30, 2009Jul 10, 2012Neotract, Inc.Anchor delivery system with replaceable cartridge
US8216260Aug 25, 2008Jul 10, 2012Usgi Medical, Inc.Apparatus and methods for forming and securing gastrointestinal tissue folds
US8241204Aug 29, 2008Aug 14, 2012Ethicon Endo-Surgery, Inc.Articulating end cap
US8252057Jan 30, 2009Aug 28, 2012Ethicon Endo-Surgery, Inc.Surgical access device
US8262563Jul 14, 2008Sep 11, 2012Ethicon Endo-Surgery, Inc.Endoscopic translumenal articulatable steerable overtube
US8262655Nov 21, 2007Sep 11, 2012Ethicon Endo-Surgery, Inc.Bipolar forceps
US8262680Sep 11, 2012Ethicon Endo-Surgery, Inc.Anastomotic device
US8317806Nov 27, 2012Ethicon Endo-Surgery, Inc.Endoscopic suturing tension controlling and indication devices
US8328837Dec 7, 2005Dec 11, 2012Xlumena, Inc.Method and apparatus for performing needle guided interventions
US8333776Aug 6, 2010Dec 18, 2012Neotract, Inc.Anchor delivery system
US8337394Oct 1, 2008Dec 25, 2012Ethicon Endo-Surgery, Inc.Overtube with expandable tip
US8342183Jan 1, 2013Vibrynt, Inc.Devices and methods for treatment of obesity
US8343187Aug 13, 2007Jan 1, 2013Neotract, Inc.Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US8353487Dec 17, 2009Jan 15, 2013Ethicon Endo-Surgery, Inc.User interface support devices for endoscopic surgical instruments
US8353925Jan 15, 2013Vibrynt, Inc.Devices and methods for treatment of obesity
US8356605Jan 22, 2013Vibrynt, Inc.Devices and methods for treatment of obesity
US8357193May 3, 2010Jan 22, 2013Xlumena, Inc.Apparatus and method for deploying stent across adjacent tissue layers
US8360069Jan 29, 2013Vibrynt, Inc.Devices and methods for treatment of obesity
US8361112Jun 27, 2008Jan 29, 2013Ethicon Endo-Surgery, Inc.Surgical suture arrangement
US8377095Feb 19, 2013Cook Medical Technologies, LLCTissue anchors for purse-string closure of perforations
US8382775Feb 26, 2013Vibrynt, Inc.Methods, instruments and devices for extragastric reduction of stomach volume
US8382776Apr 2, 2010Feb 26, 2013Cook Medical Technologies LlcMedical devices, systems and methods for rapid deployment and fixation of tissue anchors
US8394110Mar 12, 2013Neotract, Inc.Apparatus and method for manipulating or retracting tissue and anatomical structure
US8394113Mar 12, 2013Neotract, Inc.Coiled anchor device
US8398668Mar 19, 2013Vibrynt, Inc.Devices and methods for treatment of obesity
US8403926Mar 26, 2013Ethicon Endo-Surgery, Inc.Manually articulating devices
US8409200Apr 2, 2013Ethicon Endo-Surgery, Inc.Surgical grasping device
US8425505Apr 23, 2013Ethicon Endo-Surgery, Inc.Electroporation ablation apparatus, system, and method
US8425535Apr 23, 2013Neotract, Inc.Multi-actuating trigger anchor delivery system
US8425539Oct 4, 2007Apr 23, 2013Xlumena, Inc.Luminal structure anchoring devices and methods
US8449538Jan 27, 2010May 28, 2013Ethicon Endo-Surgery, Inc.Electroporation ablation apparatus, system, and method
US8454632Apr 21, 2009Jun 4, 2013Xlumena, Inc.Tissue anchor for securing tissue layers
US8454655Jun 19, 2010Jun 4, 2013Neotract, Inc.Method for anchoring suture and approximating tissue
US8460321Jun 11, 2013Vibrynt, Inc.Devices, tools and methods for performing minimally invasive abdominal surgical procedures
US8480657Oct 31, 2007Jul 9, 2013Ethicon Endo-Surgery, Inc.Detachable distal overtube section and methods for forming a sealable opening in the wall of an organ
US8480689Sep 2, 2008Jul 9, 2013Ethicon Endo-Surgery, Inc.Suturing device
US8491606Dec 27, 2010Jul 23, 2013Neotract, Inc.Median lobe retraction apparatus and method
US8491610Dec 15, 2009Jul 23, 2013Cook Medical Technologies LlcClip devices and methods of delivery and deployment
US8496574Dec 17, 2009Jul 30, 2013Ethicon Endo-Surgery, Inc.Selectively positionable camera for surgical guide tube assembly
US8500760Dec 7, 2009Aug 6, 2013Cook Medical Technologies LlcRetractable tacking device
US8506564Dec 18, 2009Aug 13, 2013Ethicon Endo-Surgery, Inc.Surgical instrument comprising an electrode
US8529563Aug 25, 2008Sep 10, 2013Ethicon Endo-Surgery, Inc.Electrical ablation devices
US8529584Dec 27, 2010Sep 10, 2013Neotract, Inc.Median lobe band implant apparatus and method
US8551139Nov 28, 2007Oct 8, 2013Cook Medical Technologies LlcVisceral anchors for purse-string closure of perforations
US8556925Oct 11, 2007Oct 15, 2013Vibrynt, Inc.Devices and methods for treatment of obesity
US8568410Apr 25, 2008Oct 29, 2013Ethicon Endo-Surgery, Inc.Electrical ablation surgical instruments
US8579897Nov 21, 2007Nov 12, 2013Ethicon Endo-Surgery, Inc.Bipolar forceps
US8585733May 28, 2009Nov 19, 2013Vibrynt, IncDevices, tools and methods for performing minimally invasive abdominal surgical procedures
US8590761 *Mar 9, 2007Nov 26, 2013Ethicon Endo-Surgery, Inc.Single fold system for tissue approximation and fixation
US8603106Jun 1, 2010Dec 10, 2013Neotract, Inc.Integrated handle assembly for anchor delivery system
US8608652Nov 5, 2009Dec 17, 2013Ethicon Endo-Surgery, Inc.Vaginal entry surgical devices, kit, system, and method
US8617196Dec 10, 2012Dec 31, 2013Xlumena, Inc.Method and apparatus for performing needle guided interventions
US8628542Dec 27, 2010Jan 14, 2014Neotract, Inc.Median lobe destruction apparatus and method
US8647368Apr 2, 2010Feb 11, 2014Cook Medical Technologies LlcTissue anchors and medical devices for rapid deployment of tissue anchors
US8652150May 30, 2008Feb 18, 2014Ethicon Endo-Surgery, Inc.Multifunction surgical device
US8663243Aug 13, 2007Mar 4, 2014Neotract, Inc.Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US8668705Aug 9, 2010Mar 11, 2014Neotract, Inc.Latching anchor device
US8668718Jun 4, 2010Mar 11, 2014Rotation Medical, Inc.Methods and apparatus for fixing sheet-like materials to a target tissue
US8679003May 30, 2008Mar 25, 2014Ethicon Endo-Surgery, Inc.Surgical device and endoscope including same
US8715239Aug 13, 2007May 6, 2014Neotract, Inc.Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US8715298Feb 8, 2013May 6, 2014Neotract, Inc.Apparatus and method for manipulating or retracting tissue and anatomical structure
US8734468Mar 28, 2011May 27, 2014Neotract, Inc.Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US8740937May 22, 2008Jun 3, 2014Cook Medical Technologies LlcSuture lock
US8758366Jul 9, 2007Jun 24, 2014Neotract, Inc.Multi-actuating trigger anchor delivery system
US8758403Jun 28, 2011Jun 24, 2014W.L. Gore & Associates, Inc.PFO closure device with flexible thrombogenic joint and improved dislodgement resistance
US8763878Jun 4, 2010Jul 1, 2014Rotation Medical, Inc.Methods and apparatus having bowstring-like staple delivery to a target tissue
US8771260May 30, 2008Jul 8, 2014Ethicon Endo-Surgery, Inc.Actuating and articulating surgical device
US8777967Dec 14, 2006Jul 15, 2014Xlumena, Inc.Methods and devices for anchoring to tissue
US8777992Mar 15, 2013Jul 15, 2014Neotract, Inc.Methods for anchoring suture and approximating tissue
US8784437 *Jun 8, 2006Jul 22, 2014Xlumena, Inc.Methods and devices for endosonography-guided fundoplexy
US8821536Jun 4, 2010Sep 2, 2014Rotation Medical, Inc.Methods and apparatus for delivering staples to a target tissue
US8821537May 8, 2013Sep 2, 2014Rotation Medical, Inc.Methods and apparatus for fixing sheet-like materials to a target tissue
US8828031Jan 12, 2009Sep 9, 2014Ethicon Endo-Surgery, Inc.Apparatus for forming an anastomosis
US8834492Dec 27, 2010Sep 16, 2014Neotract, Inc.Continuous indentation lateral lobe apparatus and method
US8834519Nov 18, 2011Sep 16, 2014Artritech, Inc.Method and device for left atrial appendage occlusion
US8840642Feb 4, 2014Sep 23, 2014Rotation Medical, Inc.Methods and apparatus for fixing sheet-like materials to a target tissue
US8863748 *Jul 31, 2008Oct 21, 2014Olympus Medical Systems Corp.Endoscopic surgical operation method
US8864780Feb 15, 2012Oct 21, 2014Rotation Medical, Inc.Methods and apparatus for delivering and positioning sheet-like materials
US8888792Jul 14, 2008Nov 18, 2014Ethicon Endo-Surgery, Inc.Tissue apposition clip application devices and methods
US8888799Feb 11, 2013Nov 18, 2014Neotract, Inc.Coiled anchor device
US8900250Aug 18, 2009Dec 2, 2014Cook Medical Technologies, LLCApparatus and methods for removing lymph nodes or anchoring into tissue during a translumenal procedure
US8900252Mar 15, 2013Dec 2, 2014Neotract, Inc.Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US8906035Jun 4, 2008Dec 9, 2014Ethicon Endo-Surgery, Inc.Endoscopic drop off bag
US8906038Feb 23, 2011Dec 9, 2014Usgi Medical, Inc.Devices and methods for laparoscopic gastric tissue reconfiguration
US8920436Jan 11, 2012Dec 30, 2014Usgi Medical, Inc.Endoscopic tissue anchor deployment
US8920464Feb 18, 2014Dec 30, 2014Rotation Medical, Inc.Methods and apparatus for fixing sheet-like materials to a target tissue
US8936609Mar 15, 2013Jan 20, 2015Neotract, Inc.Apparatus and method for manipulating or retracting tissue and anatomical structure
US8939897Feb 4, 2011Jan 27, 2015Ethicon Endo-Surgery, Inc.Methods for closing a gastrotomy
US8939996Dec 3, 2012Jan 27, 2015Neotract, Inc.Anchor delivery System
US8940001Aug 3, 2007Jan 27, 2015Neotract, Inc.Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US8945152Jul 9, 2007Feb 3, 2015Neotract, Inc.Multi-actuating trigger anchor delivery system
US8956318May 31, 2012Feb 17, 2015Valentx, Inc.Devices and methods for gastrointestinal bypass
US8986199Feb 17, 2012Mar 24, 2015Ethicon Endo-Surgery, Inc.Apparatus and methods for cleaning the lens of an endoscope
US8992547Mar 21, 2012Mar 31, 2015Ethicon Endo-Surgery, Inc.Methods and devices for creating tissue plications
US9005198Jan 29, 2010Apr 14, 2015Ethicon Endo-Surgery, Inc.Surgical instrument comprising an electrode
US9005224Oct 3, 2014Apr 14, 2015Rotation Medical, Inc.Methods and apparatus for delivering and positioning sheet-like materials
US9011431Sep 4, 2012Apr 21, 2015Ethicon Endo-Surgery, Inc.Electrical ablation devices
US9020217Sep 24, 2009Apr 28, 2015Cae Healthcare Canada Inc.Simulation of medical imaging
US9027819Jun 6, 2014May 12, 2015Rotation Medical, Inc.Methods and apparatus having bowstring-like staple delivery to a target tissue
US9028483Dec 18, 2009May 12, 2015Ethicon Endo-Surgery, Inc.Surgical instrument comprising an electrode
US9033201Feb 15, 2012May 19, 2015Rotation Medical, Inc.Methods and apparatus for fixing sheet-like materials to a target tissue
US9034001Jul 30, 2009May 19, 2015Neotract, Inc.Slotted anchor device
US9039649May 31, 2012May 26, 2015Valentx, Inc.Devices and methods for gastrointestinal bypass
US9049987Mar 15, 2012Jun 9, 2015Ethicon Endo-Surgery, Inc.Hand held surgical device for manipulating an internal magnet assembly within a patient
US9050065Jan 20, 2011Jun 9, 2015Micro Interventional Devices, Inc.Tissue repair implant and delivery device and method
US9050168May 31, 2012Jun 9, 2015Valentx, Inc.Devices and methods for gastrointestinal bypass
US9078662Jul 3, 2012Jul 14, 2015Ethicon Endo-Surgery, Inc.Endoscopic cap electrode and method for using the same
US9078749Aug 21, 2014Jul 14, 2015Georg LutterTruncated cone heart valve stent
US9089262Apr 29, 2010Jul 28, 2015Cook Medical Technologies LlcMedical systems, devices and methods for suturing perforations
US9095337May 8, 2013Aug 4, 2015Rotation Medical, Inc.Methods and apparatus for delivering staples to a target issue
US9095433Oct 18, 2011Aug 4, 2015Georg LutterTruncated cone heart valve stent
US9101460Feb 8, 2013Aug 11, 2015Rotation Medical, Inc.Implantable tendon protection systems and related kits and methods
US9107661Dec 17, 2012Aug 18, 2015Rotation Medical, Inc.Fasteners and fastener delivery devices for affixing sheet-like materials to bone or tissue
US9113866Dec 15, 2011Aug 25, 2015Ethicon Endo-Surgery, Inc.Devices and methods for endoluminal plication
US9113867Dec 15, 2011Aug 25, 2015Ethicon Endo-Surgery, Inc.Devices and methods for endoluminal plication
US9113868Dec 15, 2011Aug 25, 2015Ethicon Endo-Surgery, Inc.Devices and methods for endoluminal plication
US9113879Dec 15, 2011Aug 25, 2015Ethicon Endo-Surgery, Inc.Devices and methods for endoluminal plication
US9113977May 8, 2013Aug 25, 2015Rotation Medical, Inc.Guidewire having a distal fixation member for delivering and positioning sheet-like materials in surgery
US9119615Dec 15, 2011Sep 1, 2015Ethicon Endo-Surgery, Inc.Devices and methods for endoluminal plication
US9125650May 8, 2013Sep 8, 2015Rotation Medical, Inc.Apparatus and method for forming pilot holes in bone and delivering fasteners therein for retaining an implant
US9138211Jan 20, 2011Sep 22, 2015Micro Interventional Devices, Inc.Tissue repair implant and delivery device and method
US9149266Aug 9, 2010Oct 6, 2015Neotract, Inc.Deforming anchor device
US9155528Jan 29, 2013Oct 13, 2015Vibrynt, Inc.Methods, instruments and devices for extragastic reduction of stomach volume
US9155532May 22, 2008Oct 13, 2015Cook Medical Technologies LlcMedical devices, systems and methods for closing perforations
US9161749Apr 12, 2012Oct 20, 2015Neotract, Inc.Method and apparatus for treating sexual dysfunction
US9173657Dec 15, 2011Nov 3, 2015Ethicon Endo-Surgery, Inc.Devices and methods for endoluminal plication
US9173759May 31, 2012Nov 3, 2015Valentx, Inc.Devices and methods for gastrointestinal bypass
US9179910Mar 22, 2010Nov 10, 2015Rotation Medical, Inc.Medical device delivery system and method
US9179961Jun 4, 2010Nov 10, 2015Rotation Medical, Inc.Methods and apparatus for deploying sheet-like materials
US9198750Mar 11, 2011Dec 1, 2015Rotation Medical, Inc.Tendon repair implant and method of arthroscopic implantation
US9198751Dec 20, 2012Dec 1, 2015Rotation Medical, Inc.Methods and apparatus for delivering and positioning sheet-like materials in surgery
US9204940May 8, 2013Dec 8, 2015Rotation Medical, Inc.Anatomical location markers and methods of use in positioning sheet-like materials during surgery
US9220526Mar 20, 2012Dec 29, 2015Ethicon Endo-Surgery, Inc.Rotational coupling device for surgical instrument with flexible actuators
US9226772Jan 30, 2009Jan 5, 2016Ethicon Endo-Surgery, Inc.Surgical device
US9233241Jan 18, 2012Jan 12, 2016Ethicon Endo-Surgery, Inc.Electrical ablation devices and methods
US9247978Dec 17, 2012Feb 2, 2016Rotation Medical, Inc.Apparatus and method for forming pilot holes in bone and delivering fasteners therein for retaining an implant
US9254169Feb 28, 2011Feb 9, 2016Ethicon Endo-Surgery, Inc.Electrical ablation devices and methods
US9254192Jun 22, 2015Feb 9, 2016Georg LutterTruncated cone heart valve stent
US9259220Dec 23, 2014Feb 16, 2016Rotation Medical, Inc.Methods and apparatus for fixing sheet-like materials to a target tissue
US9265514Apr 17, 2012Feb 23, 2016Miteas Ltd.Manipulator for grasping tissue
US9271726Dec 17, 2012Mar 1, 2016Rotation Medical, Inc.Fasteners and fastener delivery devices for affixing sheet-like materials to bone or tissue
US9277957Aug 15, 2012Mar 8, 2016Ethicon Endo-Surgery, Inc.Electrosurgical devices and methods
US9314314Dec 20, 2012Apr 19, 2016Rotation Medical, Inc.Anatomical location markers and methods of use in positioning sheet-like materials during surgery
US9314331May 8, 2013Apr 19, 2016Rotation Medical, Inc.Methods and apparatus for delivering and positioning sheet-like materials in surgery
US9314362Sep 28, 2012Apr 19, 2016Vibrynt, Inc.Methods, instruments and devices for extragastric reduction of stomach volume
US9314620Feb 28, 2011Apr 19, 2016Ethicon Endo-Surgery, Inc.Electrical ablation devices and methods
US9320511Mar 15, 2013Apr 26, 2016Neotract, Inc.Multi-actuating trigger anchor delivery system
US9339265Sep 23, 2008May 17, 2016Cook Medical Technologies LlcMedical devices, systems, and methods for using tissue anchors
US9345476May 26, 2010May 24, 2016Cook Medical Technologies LlcTacking device and methods of deployment
US9364212Mar 14, 2013Jun 14, 2016Neotract, Inc.Suture anchoring devices and methods for use
US9364259Apr 9, 2010Jun 14, 2016Xlumena, Inc.System and method for delivering expanding trocar through a sheath
US9370356Dec 17, 2012Jun 21, 2016Rotation Medical, Inc.Fasteners and fastener delivery devices for affixing sheet-like materials to bone or tissue
US9375268May 9, 2013Jun 28, 2016Ethicon Endo-Surgery, Inc.Electroporation ablation apparatus, system, and method
US9381041Apr 26, 2013Jul 5, 2016Xlumena, Inc.Methods and devices for access across adjacent tissue layers
US9393103May 8, 2013Jul 19, 2016Rotation Medical, Inc.Tendon repair implant and method of arthroscopic implantation
US9393104Sep 2, 2014Jul 19, 2016Rotation Medical, Inc.Tendon repair implant and method of arthroscopic implantation
US9402711Mar 18, 2013Aug 2, 2016Neotract, Inc.Median lobe band implant apparatus and method
US9414841May 26, 2015Aug 16, 2016Rotation Medical, Inc.Fasteners and fastener delivery devices for affixing sheet-like materials to bone or tissue
US20050267533 *Jun 15, 2005Dec 1, 2005Michael GertnerMethods and devices for the surgical creation of satiety and biofeedback pathways
US20060069304 *Aug 19, 2005Mar 30, 2006Olympus CorporationEndoscopic treatment instrument, endoscopic treatment system and supporting adaptor
US20060074473 *Oct 4, 2005Apr 6, 2006Michael GertnerMethods and devices for combined gastric restriction and electrical stimulation
US20060100643 *Dec 19, 2005May 11, 2006Laufer Michael DSurgical fastening system
US20060142790 *Jan 17, 2006Jun 29, 2006Michael GertnerMethods and devices to facilitate connections between body lumens
US20060212022 *Mar 21, 2005Sep 21, 2006Boston Scientific Scimed,Inc.Tissue approximation device
US20070027358 *Sep 29, 2006Feb 1, 2007Michael GertnerDevices and methods to treat a patient
US20070162056 *Mar 9, 2007Jul 12, 2007Craig GerbiSingle fold system for tissue approximation and fixation
US20070167982 *Mar 29, 2007Jul 19, 2007Michael GertnerMethods and devices for percutaneously modifying organs to treat patients
US20070233170 *Apr 27, 2007Oct 4, 2007Michael GertnerExtragastric Balloon
US20080114381 *Nov 10, 2006May 15, 2008Voegele James WForm in place fasteners
US20080262515 *Jun 23, 2008Oct 23, 2008Joshua MakowerDevices and methods for treatment of obesity
US20080294001 *May 22, 2008Nov 27, 2008Wilson-Cook Medical Inc.Medical devices, systems and methods for closing perforations
US20090082786 *Sep 23, 2008Mar 26, 2009Wilson-Cook Medical Inc.Medical devices, systems, and methods for using tissue anchors
US20090157099 *Dec 1, 2008Jun 18, 2009Wilson-Cook Medical, Inc.Device and method for placement of tissue anchors
US20090204147 *Dec 4, 2008Aug 13, 2009Rahmani Emad YMethods and apparatuses for delivering achoring devices into body passage walls
US20090275980 *May 1, 2008Nov 5, 2009Zeiner Mark SMethod and apparatus for the formation of tissue folds
US20090281568 *Jun 14, 2007Nov 12, 2009Juan Carlos CendanDevices and Methods for Adjustable, Knotless Tissue Approximation
US20090287227 *May 28, 2009Nov 19, 2009Newell Matthew BMinimally invasive ,methods for implanting obesity treatment devices
US20100030019 *Jul 31, 2008Feb 4, 2010Kuroda NorikoEndoscopic surgical operation method
US20100042144 *Jul 29, 2009Feb 18, 2010Steven BennettMedical Device for Wound Closure and Method of Use
US20100145385 *Dec 3, 2009Jun 10, 2010Wilson-Cook Medical, Inc.Tissue anchors for purse-string closure of perforations
US20100222811 *Sep 2, 2010Gellman Barry NTissue Approximation Device
US20100234682 *May 26, 2010Sep 16, 2010Michael GertnerClosed loop gastric restriction devices and methods
US20100249700 *Mar 27, 2009Sep 30, 2010Ethicon Endo-Surgery, Inc.Surgical instruments for in vivo assembly
US20100280530 *Apr 29, 2010Nov 4, 2010Wilson-Cook Medical Inc.Medical systems, devices and methods for suturing perforations
US20110106149 *May 5, 2011Nmt Medical, Inc.Septal occluder and associated methods
US20110137394 *May 28, 2010Jun 9, 2011Xlumena, Inc.Methods and systems for penetrating adjacent tissue layers
US20110178534 *Jul 21, 2011Whitman Michael PTissue repair implant and delivery device and method
US20110178537 *Jul 21, 2011Whitman Michael PTissue repair implant and delivery device and method
US20110208209 *Aug 25, 2011Usgi Medical, Inc.Devices and methods for laparoscopic gastric tissue reconfiguration
US20110218191 *Sep 8, 2011Boehringer Ingelheim Vetmedica GmbhUse of meloxicam for the long term-treatment of kidney disorders in cats
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